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Weekly Top News – Breast Cancer – February 3, 2020

February 3, 2020

Kisqali (ribociclib) / Novartis
Kisqali: OS data from P3 MONALEESA-2 trial (NCT01958021) for postmenopausal women with advanced breast cancer in H2 2020 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results 
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Ibrance (palbociclib) / Pfizer; Erbitux (cetuximab) / Eli Lilly, EMD Serono; Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Pfizer reports fourth-quarter and full-year 2019 results provides 2020 financial guidance (Pfizer Press Release) – Jan 28, 2020 – “‘In the first half of 2020, we expect to report pivotal top-line results…in addition to the potentially registration-enabling Phase 2 ANCHOR study evaluating the combination of Braftovi, Mektovi and cetuximab for the first-line treatment of BRAFV600E-mutant metastatic colorectal cancer…In the second half of 2020, we look forward to top-line results for the Phase 3 PENELOPE-B study of Ibrance in early-stage breast cancer…we now expect the Phase 3 PALLAS study of Ibrance in early-stage breast cancer to complete in early 2021.’… In December 2019, Pfizer announced that the FDA accepted and granted priority review to the company’s supplemental New Drug Application (sNDA) for Braftovi in combination with Erbitux….The sNDA has a Prescription Drug User Fee Act goal date for a decision by the FDA in April 2020.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201: Regulatory submission in EU for HER2 positive breast cancer in Q1 FY 2020 (Daiichi Sankyo) – Feb 1, 2020 – Regulatory submission in Japan for HER2 positive gastric cancer in Q1 FY 2020 
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Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Pfizer) – Jan 28, 2020 – Q4 2019 Results 
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Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in US/EU in combination with paclitaxel for 1L TNBC in 2020 (Roche) – Jan 30, 2020 – Regulatory submissions in US/EU in combination with nab-paclitaxel for adjuvant TNBC in 2020 
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Kisqali (ribociclib) / Novartis
Kisqali: Interim analysis data from P3 NATALEE trial (NCT03701334) for adjuvant HR+, HER2(-) breast cancer in H1 2021 (Novartis) – Jan 29, 2020 – Q4 and FY 2019 Results: Final data from P3 NATALEE trial for adjuvant HR+, HER2(-) breast cancer in 2026 
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Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in early 2021 (Pfizer) – Jan 28, 2020 – Q4 2019 Results 
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tucatinib (ARRY-380) / Seattle Genetics
EMA validates Seattle Genetics’ Marketing Authorization Application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer (Seattle Genetics Press Release) – Jan 31, 2020 – “Seattle Genetics, Inc…announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens. The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process…The MAA is based on data from the pivotal HER2CLIMB clinical trial…”

 

Keytruda (pembrolizumab) / Merck (MSD); Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
DS-8201 + Keytruda: Initiation of P1b trial (NCT04042701) for breast cancer in Q4 FY 2019 (Daiichi Sankyo) – Feb 1, 2020 – Q3 FY 2019 Results
Trial initiation date

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