Weekly Top News – Breast Cancer – February 10, 2020

February 10, 2020

Piqray (alpelisib) / Novartis
Qiagen launches new breast cancer test in Europe (SeekingAlpha) – Feb 3, 2020 – “QIAGEN N.V…announces CE Mark certification of its therascreen PIK3CA RGQ PCR kit as an aid in identifying breast cancer patients with a PIK3CA mutation. Market launch is underway….The FDA approved the test last year. It is used as a companion diagnostic for Novartis’ Piqray (alpelisib).”


Piqray (alpelisib) / Novartis
EPIK-B3: Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation (clinicaltrials.gov) – Feb 5, 2020 – P3; N=566; Not yet recruiting; Sponsor: Novartis Pharmaceuticals


margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces first patients treated in separate phase 1b and registrational bridging studies (GlobeNewswire, Zai Lab Limited) – Feb 4, 2020 – “Zai Lab Limited…announced that the first patients have been dosed in two separate clinical studies: i) Phase 1b dose escalation and expansion clinical study of niraparib, in combination with MGD013, for the treatment of patients with advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (collectively as gastric cancer) who failed prior treatment, and ii) Registrational bridging study of margetuximab, in combination with chemotherapy, for the treatment of patients with metastatic HER2-positive breast cancer, respectively….Pending acceptance of the BLA, MacroGenics anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020.”


entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Regulatory approval for breast cancer in Q2 2021 (Syndax) – Feb 6, 2020 – Corporate Presentation 


Kisqali (ribociclib) / Novartis
Overall survival with ribociclib plus fulvestrant in advanced breast cancer (NEJM) – Feb 6, 2020 – 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.”


Piqray (alpelisib) / Novartis
QIAGEN launches FFPE and liquid biopsy PIK3CA diagnostics in Europe to enhance precision medicine in advanced breast cancer (Businesswire) – Feb 3, 2020 – “QIAGEN…announced the CE-marking and launch of its therascreen® PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation. Last year the therascreen PIK3CA test was approved by the FDA and launched as a companion diagnostic test for Piqray® (alpelisib) in the US…The therascreen PIK3CA test is a new diagnostic assay for detection of activating mutations in the phosphatidyl 3-kinase catalytic subunit alpha (PIK3CA) gene, and the first to enable testing of both DNA from FFPE tissue or plasma specimens.”


Perjeta (pertuzumab) / Roche; Tecentriq (atezolizumab) / Roche
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer (clinicaltrials.gov) – Feb 5, 2020 – P1; N=98; Completed; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Completed


racemetyrosine (SM-88) / Tyme
TYME announces third quarter fiscal 2020 financial and operating results (GlobeNewswire) – Feb 5, 2020 – “Second half of calendar 2020: Publish SM-88 Phase II prostate study; Advance SM-88 clinical programs into other tumor types potentially including metastatic breast, recurrent prostate and/or hematological cancers; Advance PanCAN’s Precision PromiseSM adaptive Phase II/III trial evaluating SM-88 in patients with first-line pancreatic cancer in combination with gemcitabine and Abraxane; Present and/or publish final data from Part 1 of TYME-88-Panc study; Complete enrollment in TYME-88-Panc pivotal study; Advance plans for TYME-18 IND program”

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