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Weekly Top News – Breast Cancer – May 20, 2019

May 20, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo; capivasertib (AZD5363) / Otsuka, AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca; Imfinzi (durvalumab) / AstraZeneca, Celgene; Faslodex (fulvestrant) / AstraZeneca
AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting (AstraZeneca Press Release) – May 16, 2019 – “AstraZeneca will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 31 May to 4 June 2019….In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers.”

 

Verzenio (abemaciclib) / Eli Lilly
Serious side effects of cancer drug Verzenio suspected in Japan (The Mainichi Daily News) – May 17, 2019 – “Japan’s health ministry Friday warned medical personnel of a potential side effect of breast cancer drug Verzenio on the lungs after 14 patients in the country taking the drug developed a serious lung disease and three of them died…Of the 14 cases, the drug’s adverse effects were suspected in at least four of them including one that died, according to the ministry.”

 

Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
Nab-Paclitaxel improves disease-free survival in early breast cancer: GBG 69–GeparSepto (J Clin Oncol) – May 13, 2019 – P3, N=1,200; GeparSepto (NCT01583426); “At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m2 compared with NAB-paclitaxel 150 mg/m2.”

 

Kisqali (ribociclib) / Novartis; capmatinib (INC280) / Incyte, Novartis
Novartis data at ASCO and EHA demonstrate novel approaches to reimagining medicine in cancer and serious blood disorders (PRNewswire) – May 16, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); P2, N=364; GEOMETRY mono-1 (NCT02414139); Sponsor: Novartis Pharmaceuticals; “Overall survival results from MONALEESA-7 with Kisqali (ribociclib) plus endocrine therapy in premenopausal women with HR+/HER2- advanced breast cancer, to be presented at ASCO. Primary results of GEOMETRY study for capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC) at ASCO”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to present clinical data from phase 2 triple negative breast cancer study at ASCO 2019 Annual Meeting (Biothera Press Release) – May 16, 2019 – P2, N=64; NCT02981303; Sponsor: Biothera Pharmaceuticals; “Biothera Pharmaceuticals…announced today that it will present primary clinical data from its phase 2 study in chemo-refractory metastatic triple negative breast cancer at the American Society of Clinical Oncology (ASCO) 2019 annual meeting, May 31-June 4 in Chicago. The study is evaluating Imprime PGG in combination with KEYTRUDA (pembrolizumab)…in triple negative breast cancer patients whose disease has progressed following treatment with one or more lines of chemotherapy for metastatic disease.”

 

ME-344 / MEI; Avastin (bevacizumab) / Roche
MEI Pharma to present new clinical results on ME-401 and ME-344 programs at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (MEI Pharma Press Release) – May 15, 2019 – “Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and complete results from the investigator-initiated study of ME-344 in combination with Avastin® in patients with HER2-negative breast cancer…The company also announced that an abstract on the PI3Kδ inhibitor ME-401 was selected for an oral presentation at the 15th International Conference on Malignant Lymphoma (15-ICML)….The abstract relates to updated data from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, both as a monotherapy and in combination with rituximab.”

 

Verzenio (abemaciclib) / Eli Lilly
New cancer drugs approved for NHS use in Scotland (Belfast Telegraph) – May 13, 2019 – “The Scottish Medicines Consortium (SMC) has accepted Abemaciclib (Vernezios), a drug that can prolong the time breast cancer takes to progress and delay the need for chemotherapy, allowing patients more quality time with their family…The decision on Abemaciclib (Vernezios) was welcomed by Health Secretary Jeane Freeman.”

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche
MacroGenics Announces Positive Results from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – May 15, 2019 – P3, N=530; SOPHIA (NCT02492711); Sponsor: MacroGenics; “The study met its first sequential primary endpoint of progression-free survival (PFS). The median PFS of patients treated with margetuximab and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy (hazard ratio [HR]=0.76; 95% CI: 0.59-0.98; P=0.033). Among the approximately 85% of patients carrying the CD16A 158F allele, a pre-specified exploratory subpopulation in the study, PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months; HR=0.68; 95% CI: 0.52-0.90; P=0.005). The objective response rate (ORR), a secondary outcome measure in the SOPHIA study, was 22% in the margetuximab arm (95% CI: 17.3-27.7%) compared to 16% in the trastuzumab arm (95% CI: 11.8-21.0%). The data cut-off date for the primary PFS analysis of the study was October 10, 2018.”

 

Nerlynx (neratinib) / Puma; Tykerb (lapatinib) / Novartis
Puma’s Nerlynx edges out Novartis’ Tykerb in late-stage breast cancer study (SeekingAlpha) – May 16, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology, Inc; “Results from a Phase 3 clinical trial, NALA, evaluating Puma Biotechnology’s (PBYI +3.2%) Nerlynx (neratinib) + Roche chemo agent Xeloda (capecitabine) (N + C) compared to Novartis’ (NVS +1.6%) Tykerb (lapatinib) + Xeloda (L + C) showed a treatment advantage…The overall response rate (ORR) in patients with measurable disease at study entry in the N + C arm was 33% but the difference (27% in the L + C arm) was not statistically significant….On the safety front, the incidences of treatment-related adverse events were comparable, although the rate of serious (Grade 3) diarrhea was 24% in the N + C group versus 13% in the L + C group.”

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