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Ibrance (palbociclib) / PfizerIbrance 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: 12/02/2019Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / PfizerA 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 RocheIbrance (palbociclib) / PfizerIbrance 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: 12/02/2019margetuximab (MGAH 22) / MacroGenicsMargetuximab: “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” [Screenshot]margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / RocheMacroGenics 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) / MacroGenicsMargetuximab: “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)” [Screenshot]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) / NovartisOverall 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) / NovartisRibociclib 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."
