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Pharma news roundup and Larvol updates

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Category: Breast Cancer

Weekly Top News – Breast Cancer– January 20, 2020

January 20, 2020

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Acceptance of regulatory submission for HER2 + metastatic breast cancer in Q1 2020 (Macrogenics) – Jan 17, 2020 – Corporate Presentation: PDUFA action date for HER2 + metastatic breast cancer in Q4 2020 
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NeuVax (nelipepimut-S) / SELLAS Life Sciences; Keytruda (pembrolizumab) / Merck (MSD); Opdivo (nivolumab) / Ono Pharma, BMS
SELLAS highlights clinical development progress and expected 2020 milestones (GlobeNewswire) – Jan 13, 2020 – “Expected 2020 Clinical Milestones….First patient dosed in the Phase 3 registration-enabling study of GPS in AML patients in February 2020; First patient dosed in the Phase 1 open-label study of GPS with nivolumab in MPM patients in January 2020; Interim analysis of the Phase 1/2 basket study of GPS with pembrolizumab in multiple tumor types in the second half of 2020; Guidance from the FDA on the regulatory and development pathway for NPS in TNBC patients in the first quarter of 2020; Initial data from Phase 2 trial of NPS in DCIS in the first quarter of 2020.”

 

Ibrance (palbociclib) / Pfizer
NICE approves palbociclib with fulvestrant on the CDF for treatment of some breast cancers (European Pharmaceutical Review) – Jan 15, 2020 – “The UK National Institute for Health and Care Excellence (NICE) have approved a potentially life-extending drug combination, palbociclib (Ibrance) with fulvestrant. The drugs is for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer patients, who have already had endocrine therapy. The committee made palbociclib available via the Cancer Drug Fund (CDF) after hearing patient testimony and reviewing clinical trial evidence, suggesting that palbociclib with fulvestrant increases the length of time before the disease progresses, when compared to fulvestrant alone.”

 

Verzenio (abemaciclib) / Eli Lilly
Breast Cancer Network Australia welcomes new treatment drug on the PBS (Port Macquarie News) – Jan 14, 2020 – “Breast Cancer Network Australia has praised the federal government decision to list the drug Verzenio on the Pharmaceutical Benefits Scheme…Patients could be expected to pay up to $55,500 a year to access this medicine. As a result of this listing on the PBS, they will now only pay $41 per script, or, for concessional patients, just $6.60 per script.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
CytoDyn files for Breakthrough Therapy Designation with the FDA for the use of leronlimab for the treatment of metastatic triple-negative breast cancer (GlobeNewswire) – Jan 13, 2020 – “CytoDyn Inc…announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC). The BTD filing is based on data from the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).”

 

ZW25 / Zymeworks; Ibrance (palbociclib) / Pfizer
Zymeworks announces agreement with Pfizer and initiation of a new phase 2 trial evaluating ZW25 in combination with Ibrance (palbociclib) (Businesswire) – Jan 12, 2020 – “Zymeworks Inc….announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib….The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned….Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.”

 

Bria-IMT (SV-BR-1-GM) / BriaCell; Keytruda (pembrolizumab) / Merck (MSD)
BriaCell provides update on remarkable responder (GlobeNewswire, BriaCell Therapeutics Corp) – Jan 13, 2020 – “BriaCell Therapeutics Corp….is pleased to provide an update on the previously-announced…top responder (‘Remarkable Responder’) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor. The patient, who had experienced notable tumor shrinkage while on treatment with Bria-IMT™ in combination with the PD-1 inhibitor pembrolizumab…has since transitioned to treatment in combination with INCMGA00012. On this combination treatment, the patient has had a subsequent further remarkable reduction in a breast cancer tumor behind the left eye in the left orbital region. This tumor, which had pushed the eye forward from the skull (known as proptosis), has resolved following 3 months of treatment. The tumor had shrunk by 19% during treatment with the Bria-IMT™ regimen in combination with KEYTRUDA®, and has now completely disappeared during treatment in combination INCMGA00012.”

 

Tecentriq (atezolizumab) / Roche; Opdivo (nivolumab) / Ono Pharma, BMS; Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals provides 2020 goals and financial guidance (Businesswire) – Jan 13, 2020 – “2020 IPI-549 Development Guidance: MARIO-275 enrollment completion…Phase 2 study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer. Data is expected in mid-2021; MARIO-3 enrollment completion and initial data…Phase 2 study in collaboration with Roche/Genentech to evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in triple negative breast cancer (TNBC) and with Tecentriq and Avastin® in renal cell cancer (RCC).”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $279M peak for 3L metastatic breast cancer (Infinata) – Jan 14, 2020 – A subscription to Thomson ONE is required to gain full access to report 68635802; Page no: 13; REPORT TITLE: – “Seattle Genetics, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 01/13/2020

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Weekly Top News – Breast Cancer– January 6, 2020

January 6, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”

 

Tuoyi (toripalimab) / Shanghai Junshi Bioscience
Junshi Bio and CSPC Pharma disengage from Tuoyi/paclitaxel deal (GBI Health) – Dec 31, 2019 – “China-based CSPC Pharmaceutical Group Ltd (1093.HK) and Shanghai Junshi Biosciences Co Ltd have agreed to terminate a deal struck in June 2018 in relation to programmed death-1 (PD-1) monoclonal antibody (mAb) Tuoyi (toripalimab) combined with paclitaxel in treating breast cancer. The firms cite a ‘potential conflict of interests in terms of CSPC Pharma’s PD-1 mAb development’ as the reason for the cancellation…Per the termination agreement, the milestone payments and RMB 3.68 million (527,000) in clinical development expenses paid to Junshi Bio will not be refunded, and no further milestone payments will be made.”

 

Faslodex (fulvestrant) / AstraZeneca; AZD9833 / AstraZeneca
SERENA-2: A Comparative Study of AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer (clinicaltrials.gov) – Jan 2, 2020 – P2; N=288; Not yet recruiting; Sponsor: AstraZeneca

 

Imfinzi (durvalumab) / AstraZeneca, BMS
Imfinzi sales projection: $4.8B in 2025 (Cowen & Co) – Jan 3, 2020 – A subscription to Thomson ONE is required to gain full access to report 68527170; Page no: 7; REPORT TITLE: “Portfolio manager’s weekly – December 20, 2019”; AUTHOR: Cowen Research, et al; DATE: 12/20/2019

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Weekly Top News – Breast Cancer– December 30, 2019

December 30, 2019

Piqray (alpelisib) / Novartis
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (clinicaltrials.gov) – Dec 23, 2019 – P3; N=548; Not yet recruiting; Sponsor: Novartis Pharmaceuticals

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics announces FDA acceptance for filing of Biologics License Application resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer (GlobeNewswire, Immunomedics, Inc.) – Dec 26, 2019 – “Immunomedics, Inc…today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
FDA approval of new breast cancer drug offers hope to patients with few options (Boston Herald) – Dec 27, 2019 – “A breast cancer drug that can provide a last resort option to patients who have run out of treatments has been granted accelerated approval from the Food and Drug Administration, a move that could provide a new standard of care for hundreds of thousands of women with the disease. The drug, called Enhertu, was recently granted approval for patients who have received two or more prior treatments for inoperable or metastatic HER2-positive breast cancer, a type of cancer that learns to resist the drugs designed to attack it….’It’s always really hard to know the options are getting thinner. There’s a lot we can do for HER2-positive breast cancer, though we do reach a time where there is little else we have to offer and I think having a drug like this provides a lot of hope,’ said Dr. Eric Winer…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201 regulatory estimate: Approval for 3L+ HER2+ metastatic breast cancer in Q2 2020 (SVB Leerink) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68502825; Page no: 8; REPORT TITLE: “2020 Outlook: Focus on next-generation compounds”; AUTHOR: Berens, Andrew, et al; DATE: 12/16/2019

 

tucatinib (ARRY-380) / Seattle Genetics
Seattle Genetics announces submission of tucatinib New Drug Application to the U.S. FDA for patients with locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 23, 2019 – “Seattle Genetics, Inc…announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial…”

 

Prescient Therapeutics receives encouraging efficacy results for leading cancer drug candidate PTX-200 (Small Caps) – Dec 23, 2019 – P2a, N=11; “Oncology company Prescient Therapeutics (ASX: PTX) has unveiled news of a high response rate to its PTX-200 leading drug candidate from a phase 2 breast cancer trial….In a statement to the market, Prescient said that it had received ‘encouraging efficacy results’ in a clinical trial being conducted by Professor Joseph Sparano…”

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion in November 2023 (Morgan Stanley) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68513174; Page no: 48; REPORT TITLE: “Major Pharmaceuticals: 2020 Outlook: Growth and valuation encouraging”; AUTHOR: Risinger, David, et al; DATE: 12/18/2019

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; Keytruda (pembrolizumab) / Merck (MSD)
BRCA mutations and homologous recombination repair deficiency in treatment with niraparib combined with pembrolizumab—reply (JAMA Oncology) – Dec 26, 2019 – P1/2, N=121; TOPACIO (NCT02657889); Sponsor: Tesaro, Inc; “We thank Lin and colleagues for their comments and interest in the TOPACIO/KEYNOTE-162 (Niraparib in Combination With Pembrolizumab in Patients With Triple-Negative Breast Cancer or Ovarian Cancer) trial…we found that the ORR was comparable across all ovarian cancer biomarker subpopulations, with efficacy in patients without tBRCA mutations or HRR deficiency. In the TNBC population, the ORRs were higher in patients with tBRCA mutations as expected…”

 

Afinitor (everolimus) / Novartis
ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments (clinicaltrials.gov) – Dec 27, 2019 – P; N=200; Recruiting; Sponsor: National Taiwan University Hospital

 

Imfinzi (durvalumab) / AstraZeneca, BMS
Imfinzi sales projection: Consensus of $3.5B ($2B (US: >$1B) for advanced NSCLC, $600M for 1L SCLC) by 2024 (Shore Capital) – Dec 26, 2019 – A subscription to Thomson ONE is required to gain full access to report 68483685; Page no: 5; REPORT TITLE: ” Shore Capital- Intial morning trading comments 12 December 2019”; AUTHOR: Stockbrokers Black, Clive, et al; DATE: 12/12/2019

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Weekly Top News – Breast Cancer– December 23, 2019

December 23, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Data from P3 IMpassion031 trial (NCT03197935) for neoadjuvant TNBC in H1 2020 (Roche) – Dec 17, 2019 – SABCS 2019 
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margetuximab (MGAH 22) / MacroGenics
FDA approval sought for margetuximab in HER2+ metastatic breast cancer (OncLive) – Dec 20, 2019 – “MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer….’Margetuximab’s Fc engineering enhances both innate and adaptive immunity, creating a coordinated engagement of HER2-targeted immunity,’ added Rugo.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens (AstraZeneca Press Release) – Dec 20, 2019 – “AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. This indication is approved under Accelerated Approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial…the FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01…”

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics announces submission of margetuximab Biologics License Application to U.S. FDA (GlobeNewswire) – Dec 19, 2019 – “MacroGenics, Inc…announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: “Median time to response was 1.6 months (95% CI, 1.4-2.6 months)”; Breast cancer (Daiichi Sankyo) – Dec 18, 2019 – R&D Day 2019: “Confirmed ORR: 60.9%a (95% CI, 53.4%–68.0%) 11 CRs” 
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Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at ASCO (May 29- June 02, 2020) (Daiichi Sankyo) – Dec 18, 2019 – Data presentation from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer at ASCO (May 29- June 02, 2020) 
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Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; Tecentriq (atezolizumab) / Roche
EL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) – Dec 18, 2019 – P3; N=280; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting –> Recruiting

 

Kadcyla (ado-trastuzumab emtansine) / Roche
European Commission approves Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) – Dec 19, 2019 – “Roche…announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy…The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50%…”

 

tucatinib (ARRY-380) / Seattle Genetics; Herceptin (trastuzumab) / Roche; capecitabine / Generic mfg.
Seattle Genetics announces U.S. FDA grants Breakthrough Therapy Designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 18, 2019 – “Seattle Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1…’We intend to submit a New Drug Application to the FDA and an MAA to the EMA by the first quarter 2020’…This Breakthrough Therapy designation was based on data from the pivotal HER2CLIMB clinical trial…”

 

tucatinib (ARRY-380) / Seattle Genetics
Seattle Genetics announces submission of tucatinib New Drug Application to the U.S. FDA for patients with locally advanced or metastatic HER2-positive breast cancer (Businesswire) – Dec 23, 2019 – “Seattle Genetics, Inc…announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial…”

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Weekly Top News – Breast Cancer– December 16, 2019

December 16, 2019

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Wolfe Research) – Dec 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68433460; Page no: 66; REPORT TITLE: “Global Pharmaceuticals – Dec 2019 issue of “monthly controversies” report “; AUTHOR: Anderson, Tim, et al; DATE: 12/02/2019

 

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) – Dec 9, 2019 – P3; N=400; Not yet recruiting; Sponsor: Hoffmann-La Roche

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in late 2020 (Wolfe Research) – Dec 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 68433460; Page no: 66; REPORT TITLE: “Global Pharmaceuticals – Dec 2019 issue of “monthly controversies” report “; AUTHOR: Anderson, Tim, et al; DATE: 12/02/2019

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “In this study, shorter margetuximab infusion times starting from C2 appear to be well tolerated”; Breast cancer (Macrogenics) – Dec 12, 2019 – SABCS 2019: “94% of IRRs occurred during C1 with the 120-minute infusion” 
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margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche
MacroGenics presents results from the SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer at the San Antonio Breast Cancer Symposium (GlobeNewswire) – Dec 11, 2019 – P3, N=624; SOPHIA (NCT02492711); Sponsor: MacroGenics; “MacroGenics…presented updated results from the Phase 3 SOPHIA study comparing margetuximab plus chemotherapy versus trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer…Overall survival (OS) results favored margetuximab plus chemotherapy compared with trastuzumab and chemotherapy in the intention-to-treat (ITT) population; however, these data did not reach statistical significance at this second interim analysis as of a September 2019 cut-off after 270 events (median OS=21.6 months versus 19.8 months; hazard ratio [HR]=0.89; 95% CI: 0.69-1.13; P=0.326)…’We….look forward to submitting a BLA to the FDA, which we expect to occur before the end of the year.'”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “Primary analysis (Oct-2018 cutoff): 24% risk reduction in centrally blinded PFS (HR 0.76, P=0.033)”; Breast cancer (Macrogenics) – Dec 12, 2019 – SABCS 2019: “2nd interim OS (Sep-2019 cutoff): favors margetuximab (mOS 21.6 vs 19.8 mos; HR=0.89, P=0.326)” 
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Keytruda (pembrolizumab) / Merck (MSD)
OncoSec presents interim data of 28.5% objective response rate (ORR) from ongoing KEYNOTE-890 study evaluating Tavo in combination with Keytruda for heavily pretreated, late-stage, metastatic triple negative breast cancer (mTNBC) at the 2019 San Antonio Breast Cancer Symposium (PRNewswire) – Dec 13, 2019 – P2, N=25; KEYNOTE-890 (NCT03567720); Sponsor: OncoSec Medical Incorporated; “Four of the 14 patients showed a rapid tumor reduction and had a confirmed partial response by RECIST v1.1 (ORR 28.5%), including a deep partial response in a patient with multiple liver, bone, skin and nodal metastases and a short disease-free interval following neoadjuvant chemotherapy. All responses are ongoing (range: 6 to 9 months) and a median duration of response (DOR) has not yet been reached…Stable disease was observed in three patients (21.4%), with two stable disease patients reporting 20% or greater tumor shrinkage…Additionally, 3 of the 4 responding patients’ lesions were PD-L1 negative by IHC analysis before treatment (1 patient was undetermined)…Importantly, TAVO and pembrolizumab were well tolerated, with only 3 of 16 patients experiencing grade 3 treatment-related adverse events with combination treatment….OncoSec expects to report the full data results in 2020.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
[Fam]-trastuzumab deruxtecan achieved a tumor response of 60.9% in pivotal phase II HER2-positive metastatic breast cancer trial (Businesswire) – Dec 11, 2019 – P2, N=230; DESTINY-Breast01 (NCT03248492); Sponsor: Daiichi Sankyo, Inc; “AstraZeneca and Daiichi Sankyo Company, Limited…presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of [fam]-trastuzumab deruxtecan (DS-8201)….Patients achieved a disease control rate (DCR) of 97.3% with a median duration of response (DoR) of 14.8 months (range: 13.8 – 16.9) and median progression-free survival of 16.4 months (range: 12.7 – not reached). The median overall survival (OS) has not yet been reached with an estimated survival rate for patients receiving [fam]-trastuzumab deruxtecan of 86% at one year.”

 

Kisqali (ribociclib) / Novartis
Overall survival with ribociclib plus fulvestrant in advanced breast cancer (NEJM) – Dec 11, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.00455). The benefit was consistent across most subgroups.”

 

Kisqali (ribociclib) / Novartis
Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial (Lancet Oncol) – Dec 11, 2019 – P2, N=106; CORALLEEN (NCT03248427); “At baseline, of the 106 patients, 92 (87%) patients had high ROR disease (44 [85%] of 52 in the ribociclib and letrozole group and 48 [89%] of 54 in the chemotherapy group) and 14 (13%) patients had intermediate-ROR disease (eight [15%] and six [11%]). Median follow-up was 200·0 days (IQR 191·2–206·0). At surgery, 23 (46·9%; 95% CI 32·5–61·7) of 49 patients in the ribociclib plus letrozole group and 24 (46·1%; 32·9–61·5) of 52 patients in the chemotherapy group were low-ROR.”

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Weekly Top News – Breast Cancer– December 9, 2019

December 9, 2019

BAT8001 / Bio-Thera Solutions
The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer (clinicaltrials.gov) – Dec 4, 2019 – P3; N=410; Active, not recruiting; Sponsor: Bio-Thera Solutions

 

Piqray (alpelisib) / Novartis
Alpelisib: Initiation of P3 trials for HER2+ breast cancer/TNBC/ovarian cancer/head and neck cancer in 2020 (Novartis) – Dec 6, 2019 – R&D Day 
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Piqray (alpelisib) / Novartis
Foundation Medicine expands indication for FoundationOne CDx as a companion diagnostic for Piqray (alpelisib) (Businesswire) – Dec 4, 2019 – “Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.”

 

Piqray (alpelisib) / Novartis
Alpelisib: Regulatory submissions for TNBC/HER2+ advance breast cancer in 2023 (Novartis) – Dec 6, 2019 – R&D Day: Regulatory submission for ovarian cancer in 2023; Regulatory submission for 2L/3L HNSCC in 2024 
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Keytruda (pembrolizumab) / Merck (MSD)
OncoSec to present interim data from ongoing KEYNOTE-890 study of TAVO and Keytruda in late-stage metastatic triple negative breast cancer at the 2019 San Antonio Breast Cancer Symposium (PRNewswire) – Dec 5, 2019 – “OncoSec Medical Incorporated….announced it will present interim efficacy, immunological and safety data from its ongoing KEYNOTE-890 study of TAVO™ in combination with KEYTRUDA® in patients with late-stage, heavily pretreated, chemo-refractory metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held December 10-14, 2019.”

 

Kisqali (ribociclib) / Novartis
Kisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2022 (Novartis) – Dec 6, 2019 – R&D Day 
[Screenshot]

 

Nerlynx (neratinib) / Puma, Knight Therap
Puma Biotechnology licensing partner specialised therapeutics receives marketing approval in Singapore for Nerlynx (neratinib) for extended adjuvant treatment of early stage hormone receptor positive HER2-positive breast cancer (Businesswire) – Dec 2, 2019 – “Puma Biotechnology…has received marketing approval of NERLYNX® (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government. NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.” ”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals phase 2 triple negative breast cancer data selected for Spotlight Session at San Antonio Breast Cancer Symposium (GlobeNewswire) – Dec 4, 2019 – “Biothera Pharmaceuticals, Inc. today announced that response and clinical benefit data from its Phase 2 study of dectin-1 agonist Imprime PGG in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in chemo-refractory metastatic triple negative breast cancer patients have been selected for a poster discussion Spotlight Session on December 11 at the 2019 San Antonio Breast Cancer Symposium.”

 

Verzenio (abemaciclib) / Eli Lilly
Eli Lilly stretches 2019 Verzenio approvals streak with Peru nod (GBI Health) – Dec 6, 2019 – “GBI analysis reveals that Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) this week granted Eli Lilly market approval for its kinase inhibitor Verzenio (abemaciclib). The oral therapy is designed to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, although the agency does not release indication details.”

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics resubmits Biologics License Application to the FDA for sacituzumab govitecan (GlobeNewswire) – Dec 3, 2019 – “Immunomedics, Inc…today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.”

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Weekly Top News – Breast Cancer – December 2, 2019

December 2, 2019

Ibrance (palbociclib) / Pfizer
NICE backs Ibrance for breast cancer via cancer drugs fund (pharmaphorum) – Nov 28, 2019 – “Pfizer’s Ibrance has been approved for use by the NHS in England as a second-line treatment for advanced breast cancer after hormonal therapy, catching up with rival drugs in the class. The decision by NICE means that CDK4/6 inhibitor Ibrance (palbociclib) will be made available for patients via the Cancer Drugs Fund (CDF), which covers the cost of cancer drugs until confirmatory data is available.”

 

Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; Tecentriq (atezolizumab) / Roche
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial (Lancet Oncol) – Nov 27, 2019 – P3, N=900; IMpassion130 (NCT02425891); Sponsor: Hoffmann-La Roche; “At the second interim analysis (data cutoff Jan 2, 2019), median follow-up was 18·5 months (IQR 9·6–22·8) in the atezolizumab group and 17·5 months (8·4–22·4) in the placebo group. Median overall survival in the intention-to-treat patients was 21·0 months (95% CI 19·0–22·6) with atezolizumab and 18·7 months (16·9–20·3) with placebo (stratified hazard ratio [HR] 0·86, 95% CI 0·72–1·02, p=0·078). In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6–30·7) with atezolizumab versus 18·0 months (13·6–20·1) with placebo (stratified HR 0·71, 0·54–0·94]).”

 

Tecentriq (atezolizumab) / Roche
Chugai launches Tecentriq intravenous infusion 840 mg as an optimal formulation for the treatment of PD-L1-positive inoperable or metastatic triple negative breast cancer (Chugai Press Release) – Nov 26, 2019 – “Chugai Pharmaceutical…announced that an anticancer agent/anti-PD-L1 (Programmed Death-Ligand 1) monoclonal antibody Tecentriq® Intravenous Infusion 840 mg…has been listed on the National Health Insurance (NHI) reimbursement price list and launched today. Tecentriq 840 mg is an optimal formulation to be dosed every two weeks for the treatment of PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer. This additional indication and dosage were approved on September 20, 2019.”

 

sacituzumab govitecan (IMMU-132) / Immunomedics
IMMU-132 clinical trial estimate: Data from P3 ASCENT trial (NCT02574455) for TNBC in mid-2020 (Zacks) – Nov 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68305709; Page no: 3; REPORT TITLE: “Immunomedics, Inc.(IMMU) Zacks company report”; AUTHOR: Research Department; DATE: 11/08/2019

 

Ibrance (palbociclib) / Pfizer
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) – Nov 25, 2019 – P; N=1; Active, not recruiting; Sponsor: Pfizer

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Health Canada approves Kadcyla (trastuzumab emtansine) for the treatment of HER2-positive early breast cancer after surgery (Canada Newswire) – Nov 28, 2019 – “Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) taxane and trastuzumab-based treatment…Health Canada’s approval is based on results of the Phase III KATHERINE study…”

 

National Medical Products Administration (NMPA) approves Chipscreen Bioscience’s chidamide (Epidaza) for breast cancer indication (PRNewswire) – Nov 29, 2019 – “On November 29, 2019, Shenzhen Chipscreen Biosciences Co., Ltd….announced that the company’s lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor…has received approval for marketing application in its second indication from NMPA. The indication includes Chidamide combined with aromatase inhibitor in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression.”

 

Ogivri (trastuzumab biosimilar) / Biocon, Mylan
Mylan and Biocon launch trastuzumab biosimilar, Ogivri (trastuzumab-dkst), in the U.S. (PRNewswire) – Dec 2, 2019 – “Mylan N.V….and Biocon Ltd….announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility….Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma)…. FDA approval of Ogivri was based on robust data demonstrating that Ogivri…results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting.”

 

Talzenna (talazoparib) / Pfizer; Keytruda (pembrolizumab) / Merck (MSD)
A Study of ZN-c3 in Participants With Solid Tumors (clinicaltrials.gov) – Nov 25, 2019 – P1/2; N=360; Recruiting; Sponsor: K-Group Beta; Not yet recruiting –> Recruiting

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Weekly Top News – Breast Cancer – November 25, 2019

November 25, 2019

margetuximab (MGAH 22) / MacroGenics
Margetuximab US regulatory estimate: Approval for HER2+ metastatic breast cancer in H1 2020 (Cowen & Co) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68286929; Page no: 2; REPORT TITLE: “Margetuximab BLA in 4Q19; Flotetuzumab data in AML at ASH 2019”; AUTHOR: Peaker, Boris, et al; DATE: 11/06/2019

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab launch estimate: 2020 for breast cancer and 2022 for gastric cancer (BTIG) – Nov 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68154141; Page no: 2; REPORT TITLE: “MacroGenics, Inc. – More mature data from SOPHIA looking cleaner with 158F OS HR=0.79”; AUTHOR: Shrader, Thomas, et al; DATE: 10/23/2019

 

GDC-9545 / Roche; Herceptin (trastuzumab) / Roche; ipatasertib (GDC-0068) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Businesswire) – Nov 18, 2019 – “Genentech…announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019…New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC)…Genentech will also present data from the primary analysis of the Phase III FeDeriCa study…”

 

Piqray (alpelisib) / Novartis
Alpelisib: “The Committee was reminded of the status of this application and its remaining outstanding issues [treatment of HR-positive/HER2-negative, advanced breast cancer in combination with fulvestrant]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of outstanding issues with a specific timetable.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca; Kadcyla (ado-trastuzumab emtansine) / Roche; U3-1402 / Daiichi Sankyo
Positive pivotal data for Daiichi Sankyo’s DS-8201 ([fam]-trastuzumab deruxtecan) in patients with HER2 positive metastatic breast cancer to be presented at SABCS (Businesswire) – Nov 19, 2019 – “Positive data from the pivotal phase 2 DESTINY-Breast01 trial of DS-8201 ([fam-] trastuzumab deruxtecan), an investigational HER2 targeting antibody drug conjugate (ADC), will be unveiled….Trial-in-progress updates from the pivotal phase 3 development program of DS-8201 in patients with HER2 positive metastatic breast cancer, including a head-to-head study with ado-trastuzumab emtansine, and in patients with HER2 low metastatic breast cancer, also will be presented. An overview of the phase 1/2 trial for U3-1402, an investigational HER3 targeting ADC, in HER3 expressing advanced/unresectable or metastatic breast cancer also will be featured at SABCS.”

 

Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
Breast and kidney cancer drugs approved on NHS Scotland (Medical Xpress) – Nov 22, 2019 – “Lenvatinib has been accepted for use in combination with another targeted drug called everolimus (Afinitor), which stops cancer growing by starving it of blood…Access to the targeted treatment ribociclib has also been approved for some women with breast cancer in Scotland whose cancer has spread near to where their tumor first appeared, or to another part of the body….Based on the clinical trial evidence presented by atezolizumab’s manufacturer, the SMC decided the treatment did not offer enough value to patients for the drug combination to be cost effective.”

 

sacituzumab govitecan (IMMU-132) / Immunomedics
IMMU-132 clinical trial estimate: Data from P3 ASCENT trial (NCT02574455) for TNBC in mid-2020 (Zacks) – Nov 25, 2019 – A subscription to Thomson ONE is required to gain full access to report 68305709; Page no: 3; REPORT TITLE: “Immunomedics, Inc.(IMMU) Zacks company report”; AUTHOR: Research Department; DATE: 11/08/2019

 

tremelimumab (CP-675206) / AstraZeneca, Pfizer; Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
GUIDE2REPAIR: Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment (clinicaltrials.gov) – Nov 20, 2019 – P2; N=270; Not yet recruiting; Sponsor: Centre Georges Francois Leclerc

 

Ibrance (palbociclib) / Pfizer
Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) – Nov 25, 2019 – P; N=1; Active, not recruiting; Sponsor: Pfizer

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Kadcyla: “The Committee discussed the issues identified in this application, mainly relating to the wording of the indication in relation to the studied population and the request for 1 year of market protection [extension of indication to include the adjuvant treatment of adult patients with HER2-positive early breast cancer]”. (EMEA) – Nov 19, 2019 – CHMP Final Minutes for the meeting on 16-19 September 2019: “The Committee adopted a 2nd request for supplementary information with a specific timetable.”

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Weekly Top News – Breast Cancer – November 18, 2019

November 18, 2019

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Launch in US for breast cancer in 2021 (Syndax) – Nov 11, 2019 – Q3 2019 Results

 

Tecentriq (atezolizumab) / Roche; Kisqali (ribociclib) / Novartis; Lenvima (lenvatinib) / Eisai, Merck (MSD)
NHS Scotland adopts five new medicines (Holyrood Magazine) – Nov 11, 2019 – “Medicines to treat kidney and breast cancer are among five new treatments which have been accepted for use within NHS Scotland, by the Scottish Medicines Consortium (SMC). Ribociclib (Kisqali) for breast cancer treatment, lenvatinib (Kisplyx) for kidney cancer…were all accepted for use in the NHS after SMC committee members heard a range of evidence on the medications…However, the SMC also rejected an immunotherapy drug, known as atezolizumab. The medicine is used to treat patients with bladder of urinary cancer, or non-small cell lung cancer (NSCLC).”

 

GDC-9545 / Roche; Herceptin (trastuzumab) / Roche; ipatasertib (GDC-0068) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium (Businesswire) – Nov 18, 2019 – P3, N=500; FeDeriCa (NCT03493854); Sponsor: Hoffmann-La Roche; P3, N=4,804; APHINITY (NCT01358877); Sponsor: Hoffmann-La Roche; “Genentech…announced that results from a number of studies across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 10-14, 2019…New data will be presented from a second interim overall survival (OS) analysis of the Phase III APHINITY trial evaluating Perjeta® (pertuzumab) and Herceptin® (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC)….Genentech will also present data from the primary analysis of the Phase III FeDeriCa study…”

 

Keytruda (pembrolizumab) / Merck (MSD)
OncoSec presents immunological data associated with positive tumor response from Tavo KEYNOTE studies evaluating patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting (PRNewswire) – Nov 12, 2019 – P2, N=100; PISCES (NCT03132675); Sponsor: OncoSec Medical Incorporated; P2, N=25; KEYNOTE-890 (NCT03567720); Sponsor: OncoSec Medical Incorporated; “The interim analysis also highlighted the systemic immune effects of TAVO, including increases in the frequencies of circulating memory T cells and reduced frequencies of circulating immuno-suppressive PMN-MDSC cells in predominately responding patients across both indications. Additionally, a broad safety analysis of over 200 patients treated with TAVO in multiple cancer indications across several clinical trials including TAVO as a monotherapy as well as in combination with KEYTRUDA was reported….underscoring a predictable and consistently well-tolerated safety profile.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (GlobeNewswire) – Nov 15, 2019 – “Roche…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy. Based on this recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future….The recommendation from the CHMP is based on results from the phase III KATHERINE study…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
AZ’s Lynparza is first PARP inhibitor to enter Cuba market (GBI Health) – Nov 15, 2019 – “According to GBI analysis, UK-based AstraZeneca last week obtained marketing approval from Cuba’s Center for State Control of Drugs and Medical Devices (CECMED) for its oncology therapy Lynparza (olaparib). The oral drug is used a treatment against breast cancer susceptibility gene (BRCA)-mutated ovarian and breast cancers. However, the agency does not publish indication details.”

Lenvima (lenvatinib) / Eisai, Merck (MSD); Halaven (eribulin mesylate) / Eisai
Biotoscana heralds upcoming arrival of Eisai’s Lenvima, Halaven to Argentina (GBI Health) – Nov 11, 2019 – “Biotoscana, a subsidiary of Canada’s Knight Therapeutics, last week announced plans to launch Eisai’s oncology drugs Halaven (eribulin mesylate) and Lenvima (lenvatinib) to the Argentina market in December 2019 or January 2020. The treatments were in-licensed by Biotoscana for Latin America ex-Mexico in 2017, as GBI reported…Halaven’s registration filing is as a breast cancer treatment, while Lenvima’s indications are against hepatic, kidney, and thyroid cancers.”

 

Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCell
BriaCell to present clinical findings at the 2019 San Antonio Breast Cancer Symposium December 12th and 13th (GlobeNewswire) – Nov 12, 2019 – P1/2, N=60; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….is pleased to announce its lead product candidate, Bria-IMT™, will be featured in two poster sessions during the 2019 San Antonio Breast Cancer Symposium® (SABCS) taking place December 10-14 in San Antonio, Texas.”

 

Verzenio (abemaciclib) / Eli Lilly
Lilly’s breast cancer therapy abemaciclib market filing accepted for review in China (GBI Health) – Nov 15, 2019 – “According to the Center for Drug Evaluation’s (CDE) website, US major Eli Lilly’s market filing for import of CDK4/6 inhibitor abemaciclib has been accepted for review. Abemaciclib is a cell-cycle inhibitor designed to block the growth of cancer cells by specifically inhibiting CDK4/6. Lilly initiated a multi-center Phase III clinical trial including China that enrolled 450 post-menopausal patients globally suffering from locally recurrent or metastatic breast cancer, with 360 of those to be in China, as GBI reported in 2016. The MONARCH plus Phase III clinical study was concluded ahead of schedule…”

Syros reports third quarter 2019 financial results and highlights key accomplishments and upcoming milestones (Syros Press Release) – Nov 12, 2019 – “Syros plans to complete enrollment in the newly diagnosed unfit AML cohorts of the ongoing Phase 2 trial in the fourth quarter of this year…Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in RARA-positive patients with relapsed or refractory AML in 2020; Syros plans to complete investigational new drug application-enabling studies by year-end and initiate a Phase 1 trial of SY-5609 in the first quarter of 2020 in patients with select solid tumors, including breast, lung and ovarian cancers…”

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Weekly Top News – Breast Cancer – November 11, 2019

November 11, 2019

Tecentriq (atezolizumab) / Roche; Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
EL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) – Nov 5, 2019 – P3; N=280; Not yet recruiting; Sponsor: Hoffmann-La Roche

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Second interim OS data from P3 SOPHIA trial (NCT02492711) in HER2+ metastatic breast cancer at SABCS (Dec 10- 14, 2019) (Macrogenics) – Nov 9, 2019 – Corporate Presentation 
[Screenshot]

 

llllllllll entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Launch in US for breast cancer in 2021 (Syndax) – Nov 11, 2019 – Q3 2019 Results
Launch US

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports third quarter 2019 financial results and provides clinical and business update (PRNewswire) – Nov 7, 2019 – P3, N=600; E2112 (NCT02115282); P1/2, N=132; AUGMENT-101 (NCT04065399); Sponsor: Syndax Pharmaceuticals; “Pipeline updates: (i) Entinostat: E2112 trial passed final interim OS analysis; trial continues, with final OS analysis expected in 2Q20; (ii) SNDX-5613: The Company expects to report initial clinical data from the…phase 1/2 open-label AUGMENT-101 trial…in 2020.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P2 MARIO-3 trial (NCT03961698) in combination with IPI-549 and Abraxane for 1L TNBC or 1L RCC at year end 2020 (Jones Trading) – Nov 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 68239157; Page no: 1; REPORT TITLE: “Infinity Pharmaceuticals, Inc.-3Q19 — Reiterating BUY & $3.50 PT. Mature phase 1b data potentially in mid/3Q20 likely to provide mechanistic insight; Phase 2 MARIO-3 data at YE20-10/31/2019 “; AUTHOR: Roy, Soumit, et al; DATE: 10/31/2019

 

Keytruda (pembrolizumab) / Merck (MSD)
Study of DF1001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) – Nov 5, 2019 – P1/2; N=220; Not yet recruiting; Sponsor: Dragonfly Therapeutics

 

Verzenio (abemaciclib) / Eli Lilly
COFEPRIS clears Eli Lilly’s onco drug Verzenio for Mexico market (GBI Health) – Nov 4, 2019 – “Eli Lilly last week announced the receipt of a marketing approval from Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) for its anti-cancer treatment Verzenio (abemaciclib). The oral drug is indicated as part of a first- or second-line combination therapy against hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to Present Immune Pharmacodynamic Data (IPD) Showing Immune Activation in Phase 2 Melanoma and Triple Negative Breast Cancer Study (GlobeNewswire, Biothera Pharmaceuticals, Inc.) – Nov 8, 2019 – P2, N=164; NCT02981303; Sponsor: Biothera; “In three previous mTNBC studies, CPI monotherapies resulted in a disease control rate of 7-10% (CR +PR+ SD >24 weeks), median overall survival (mOS) of 7-9 months and a 12-month OS of 37-40%. Primary data from the 44-patient Phase 2 study evaluating Imprime PGG and KEYTRUDA show a disease control rate of 25% (N= 11; 1 CR, 6 PR and 4 SD>24 weeks), mOS of 16.4 months and 12-month OS rate of 57.6%….Similar results were observed in the melanoma arm of the study, which tested the combination of Imprime PGG and KEYTRUDA in heavily CPI pre-treated melanoma patients (20 patients; 13/20 had ³2 prior CPI regimens and 17/20 had progressed on pembrolizumab). The disease control rate was 50% (1 CR and 9 SD as best response), 12-month OS rate was 45%.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Kisqali (ribociclib) / Novartis; veliparib (ABT-888) / AbbVie; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD); Zejula (niraparib) / GSK, J&J, Takeda
2019 Post European Society for Medical Oncology (ESMO) Report: Highlights from ESMO 2019 Congress – ResearchAndMarkets.com (Businesswire) – Nov 4, 2019 – “Conference highlights included new data from PARP inhibitors in ovarian cancer, such as Zejula, Lynparza and veliparib, as well as a follow-up update for KRAS-targeted drug AMG 510 for colorectal cancer, and CDK4/6-inhibitors, Kisqali and Verzenio, for breast cancer. Key pipeline updates for more established drugs were highly featured including Keytruda for non-small lung cancer and Kisqali for breast cancer.”

 

Nerlynx (neratinib) / Puma
CANbridge receives Hong Kong Department of Health market approval for Nerlynx (Businesswire) – Nov 5, 2019 – “CANbridge Pharmaceuticals Inc….announced that it received market approval from the Department of Health in Hong Kong for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early‑stage hormone receptor positive HER2-overexpressed/amplified breast cancer, and who completed adjuvant trastuzumab-based therapy less than one year ago.”

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