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 


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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