Weekly Top News – Breast Cancer – August 5, 2019

August 5, 2019

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct phase III trials (GlobeNewswire) – Jul 31, 2019 – P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; “Novartis today announced Kisqali®(ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial. MONALEESA-3 evaluated efficacy and safety of Kisqali plus fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in both the first-line and second-line settings….No new safety signals were observed; adverse events were consistent with previously reported Phase III trial results.”


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Regulatory submission in EU for HER2 positive breast cancer in Q1 FY 2020 (Daiichi Sankyo) – Aug 1, 2019 – Q1 FY 2019 Results: Regulatory submission in Japan for HER2 positive gastric cancer in Q1 FY 2020


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019


Keytruda (pembrolizumab) / Merck (MSD)
Merck’s Keytruda (pembrolizumab) in combination with chemotherapy met primary endpoint of pathological complete response (pCR) in pivotal phase 3 KEYNOTE-522 trial in patients with triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) – Jul 29, 2019 – P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck; “Merck…announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status.”


Verzenio (abemaciclib) / Eli Lilly
Lilly’s Verzenio (abemaciclib) significantly extended life in women with HR+, HER2- advanced breast cancer in MONARCH 2 (Eli Lilly Press Release) – Jul 30, 2019 – P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly and Company; “The analysis showed that treatment with Verzenio in combination with fulvestrant met its secondary endpoint of overall survival. The MONARCH 2 study previously demonstrated a statistically significant improvement in progression-free survival, the trial’s primary endpoint which served as the basis for its approval of this regimen in more than 50 countries around the world. No new safety signals were observed in this analysis of MONARCH 2, consistent with the established safety profile of Verzenio…. Lilly plans to submit these data to regulatory authorities and present the detailed data at an upcoming medical meeting later this year.”


Verzenio (abemaciclib) / Eli Lilly
Verzenio: OS data from P3 MONARCH-2 trial (NCT02107703) in HER2- breast cancer in 2020 (Eli Lilly) – Jul 31, 2019 – Q2 2019 Results


entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
KHK2375: Completion of P2 trial (NCT03291886) for advanced or recurrent hormone receptor-positive breast cancer in November 2021 (Kyowa Hakko Kirin Pharma) – Aug 2, 2019 – Q2 2019 Results



Tecentriq (atezolizumab) / Roche; Avastin (bevacizumab) / Roche; Opdivo (nivolumab) / Ono Pharma, BMS; IPI-549 / Infinity Pharma
Infinity Pharmaceuticals provides company update and second quarter 2019 financial results(PRNewswire) – Jul 30, 2019 – “Recent developments include: MARIO-3 Initiating in Q3 – This Phase 2 study in collaboration with Roche/Genentech will evaluate IPI-549 in novel triple combination front-line therapies with Tecentriq® and Abraxane® in TNBC and with Tecentriq and Avastin® in RCC; Arcus Biosciences Collaboration Study Initiating in Q3 – This Phase 1 trial, to be conducted by Arcus, will evaluate a checkpoint-inhibitor free, novel triple-combination regimen of IPI-549 + AB928 (dual adenosine receptor antagonist) + Doxil® in advanced TNBC patients; Completing MARIO-1 by year end – Infinity anticipates completing enrollment in the second half of 2019 in the expanded combination cohorts in MARIO-1, the company’s ongoing Phase 1/1b study of IPI-549 as a monotherapy and in combination with Opdivo in approximately 225 patients with advanced solid tumors.”



Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from early P1 trial (NCT03599453) in combination with Ampligen, Intron A and celecoxib for TNBC by 2020 (GlobalData) – Aug 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67689228; Page no: 176; REPORT TITLE: “Hemispherx Biopharma Inc (HEB) – Financial and strategic SWOT analysis Review”; AUTHOR: GlobalData; DATE: 08/01/2019


Ogivri (trastuzumab biosimilar) / Biocon, Mylan
Mylan, Biocon launch biosimilar of cancer drug Herceptin in Australia (Bloomberg Quint) – Aug 1, 2019 – “Biocon Ltd. and Mylan NV on Thursday launched Ogivri, used for treatment of certain breast and stomach cancers, in Australia. It is a biosimilar of Hoffmann-La Roche’s Herceptin.”

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