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Tecentriq (atezolizumab) / RocheHealth Canada approves Tecentriq in combination with chemotherapy (nab-paclitaxel) as first immunotherapy treatment for aggressive form of breast cancer (Canada Newswire) - Sep 27, 2019 - "Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada under the Notice of Compliance with Conditions (NOC/c) policy has approved Tecentriq® (atezolizumab) in combination with chemotherapy (nab-paclitaxel) for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1%, and who have not received prior chemotherapy for metastatic disease. Tecentriq is the first and only approved cancer immunotherapy agent in Canada for first-line TNBC. This approval meets a significant unmet need for TNBC patients...This approval is based on results from the randomized Phase III IMpassion130 study."Verzenio (abemaciclib) / Eli LillyVerzenio (abemaciclib) significantly extends life by a median of 9.4 months for women with HR+, HER2- advanced breast cancer in MONARCH 2 study (Eli Lilly Press Release) - Sep 29, 2019 - P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly; "Eli Lilly and Company...announced Verzenio® (abemaciclib) in combination with fulvestrant significantly extended life by a median of 9.4 months in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy (median of 46.7 months vs. median of 37.3 months with placebo plus fulvestrant; HR: 0.757; 95% CI: 0.606, 0.945; P = 0.0137). Results from the Phase 3 MONARCH 2 clinical trial, which included both pre/peri- and postmenopausal women, were consistent across subgroups."Keytruda (pembrolizumab) / Merck (MSD)Merck’s Keytruda (pembrolizumab) plus chemotherapy showed statistically significant increase in pathological complete response versus chemotherapy as neoadjuvant therapy in early-stage triple-negative breast cancer (TNBC) (Merck (MSD) Press Release) - Sep 29, 2019 - P3, N=1,174; KEYNOTE-522 (NCT03036488); Sponsor: Merck Sharp & Dohme Corp; "Merck...announced results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial in patients with early-stage triple-negative breast cancer (TNBC)...In the neoadjuvant phase, KEYTRUDA plus chemotherapy (n=401) resulted in a statistically significant increase in pathological complete response (pCR) versus chemotherapy (n=201), from 51.2% with neoadjuvant chemotherapy to 64.8% for neoadjuvant KEYTRUDA plus chemotherapy, in patients with early-stage TNBC (p=0.00055)....In the PD-L1 CPS ≥1 subgroup, the rates of pCR were 68.9% for neoadjuvant KEYTRUDA plus chemotherapy (n=334) versus 54.9% for neoadjuvant chemotherapy (n=164)."Kisqali (ribociclib) / NovartisNovartis Kisqali delivers consistently superior overall survival – MONALEESA-3 trial demonstrates more life for postmenopausal HR+/HER2- advanced breast cancer patients (Novartis Press Release) - Sep 29, 2019 - P3, N=726; MONALEESA-3 (NCT02422615); Sponsor: Novartis Pharmaceuticals; "Novartis today announced results from the MONALEESA-3 trial, which showed Kisqali® (ribociclib) achieved statistically significant improvement in overall survival (OS)...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....Median PFS in the first-line was also reached at this analysis and demonstrated that Kisqali in combination with fulvestrant has a median PFS of 33.6 months compared to 19.2 months in the placebo arm (HR=0.546; 95% CI: 0.415-0.718)."Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)Eisai announces data presentations on Keytruda (pembrolizumab) plus Lenvima (lenvatinib) investigational combination therapy and Halaven (eribulin) at ESMO 2019 (PRNewswire) - Sep 24, 2019 - P3, N=720; ENGOT-en9 (NCT03884101); Sponsor: Merck Sharp & Dohme Corp; P3, N=392; SELECT (NCT01321554); Sponsor: Eisai Inc; P3, N=694; LEAP-011 (NCT03898180); Sponsor: Merck Sharp & Dohme Corp; “Eisai today announced the presentation of new data and analyses via one oral proffered paper presentation, four poster discussions and seven poster presentations at the 2019 European Society for Medical Oncology (ESMO) Annual Meeting from September 27 – October 1 in Barcelona, Spain. Data to be presented include posters on the ongoing trials evaluating pembrolizumab plus lenvatinib…”Tecentriq (atezolizumab) / Roche; sacituzumab govitecan (IMMU-132) / ImmunomedicsImmunomedics provides corporate update (GlobeNewswire) - Sep 28, 2019 - “The collaboration with Roche will evaluate the safety and efficacy of the combination of atezolizumab (Tecentriq®)…and sacituzumab govitecan, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC…. The open-label, multicenter, randomized Phase 1b/2 study will be conducted as part of MORPHEUS…. Roche will be responsible for conducting the randomized trial….Immunomedics and the GBG Forschungs-GmbH (GBG), Neu-Isenburg, Germany, have entered into a collaboration to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response (pCR) following standard neoadjuvant therapy…. The multinational, post-neoadjuvant Phase 3 SASCIA study developed by GBG will be conducted under the sponsorship of GBG.”Cyramza (ramucirumab) / Eli Lilly; Tarceva (erlotinib) / Astellas, Roche; pemetrexed / Generic Mfg.; Verzenio (abemaciclib) / Eli Lilly; Keytruda (pembrolizumab) / Merck (MSD)Lilly Oncology to present robust data across its growing portfolio at ESMO 2019 (Eli Lilly Press Release) - Sep 23, 2019 - P3, N=669; MONARCH 2 (NCT02107703); Sponsor: Eli Lilly and Company; P1/2, N=970; LIBRETTO-001 (NCT03157128); Sponsor: Loxo Oncology, Inc; P3, N=543; RELAY (NCT02411448); Sponsor: Eli Lilly and Company; “Verzenio® (abemaciclib) Phase 3 data included in ESMO Presidential Symposium and Official Press Program: Positive overall survival results to be presented from MONARCH 2, evaluating Verzenio with fulvestrant for the treatment of women with HR+, HER2- advanced breast cancer whose cancer grew or spread following endocrine therapy; RET-altered thyroid cancer data for selpercatinib (LOXO-292) from the Phase 1/2 LIBRETTO-001 study to be featured in late-breaking oral presentation; Lung cancer highlights to include presentation of data from the Phase 3 CYRAMZA® (ramucirumab) RELAY trial and studies of the ALIMTA® (pemetrexed)-KEYTRUDA® (pembrolizumab)-platinum chemotherapy combination.”Keytruda (pembrolizumab) / Merck (MSD); Opdivo (nivolumab) / Ono Pharma, BMS; Kadcyla (ado-trastuzumab emtansine) / Roche; Ibrance (palbociclib) / PfizerFlatiron Health announces research to be presented at European Society for Medical Oncology Congress 2019 (Businesswire) - Sep 26, 2019 - "Flatiron Health today announced 13 abstracts accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2019, which will be held September 27 – October 1, 2019, in Barcelona, Spain. The research, spanning multiple tumor types and areas of study, utilized Flatiron's high-quality, real-world oncology datasets."Ibrance (palbociclib) / PfizerPfizer presents new evidence of Ibrance (palbociclib) effectiveness in HR+, HER2- metastatic breast cancer patients in four real-world studies at ESMO Congress 2019 (Businesswire) - Sep 24, 2019 - “Pfizer Inc….announced the presentation of four IBRANCE® (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.”Kadcyla (ado-trastuzumab emtansine) / Roche; Tecentriq (atezolizumab) / RocheRoche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress (Roche Press Release) - Sep 23, 2019 - "Roche...announced that results from a number of studies across its comprehensive oncology portfolio, covering a broad range of cancers including bladder, lung and breast will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress, taking place from 27 September - 1 October in Barcelona, Spain. A total of 100 abstracts and 15 late-breaking abstracts that include a Roche medicine will be presented at this year’s congress....First positive results from a Phase III cancer immunotherapy combination study in people with previously untreated advanced bladder cancer....First results from the BFAST study testing Foundation Medicine’s FoundationOne® Liquid biopsy assay to identify patients who may be eligible for Alecensa® (alectinib)....First results from the positive Phase III IMpower110 study of Tecentriq® (atezolizumab) monotherapy as an initial treatment for advanced lung cancer."
