Oncology

Merck’s Keytruda with Chemotherapy Significantly Improved OS and PFS Compared with Chemotherapy in Locally Advanced or First-Line Metastatic Esophageal Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (cisplatin plus 5-fluorouracil [5-FU]), met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the …

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Precision BioSciences Receives Fast Track Disease Designation from FDA for PBCAR0191 Investigational Allogeneic CAR T Cell Therapy

DURHAM, N.C., Aug. 19, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Precision for PBCAR0191, the company’s …

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Lilly and Innovent Announce Global Expansion of TYVYT Licensing Agreement

INDIANAPOLIS and SUZHOU, China, Aug. 18, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Innovent Biologics, Inc. (HKEX: 01801) today announced a global expansion of their strategic alliance for TYVYT® (sintilimab injection), an anti-PD-1 monoclonal antibody immuno-oncology medicine that was co-developed by Innovent and Lilly in China. In 2019, Lilly and Innovent began commercializing TYVYT in China after being granted marketing approval …

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Immunicum Announces Update on Survival Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer

Immunicum AB (publ) announced today an update on survival data from the randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with Sutent® (sunitinib) first-line treatment regimen in newly diagnosed patients with metastatic renal cell carcinoma (mRCC). During the trial, 88 patients were randomly assigned in a two-to-one …

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Gilead Sciences and Tango Therapeutics to Expand Strategic Oncology Collaboration

FOSTER CITY, Calif. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Tango Therapeutics today announced an expanded strategic collaboration focused on the discovery, development and commercialization of innovative targeted immune evasion therapies for patients with cancer. Under the expanded multi-year collaboration, which builds on an agreement signed in 2018, …

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Additional Data from Clovis Oncology’s Clinical Trial Evaluating Rubraca for the Treatment of mCRPC in Patients with BRCA1/2 Gene Mutations Published

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that data from the Phase 2 TRITON2 study of Rubraca® (rucaparib) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) harboring BRCA1/2 mutations were published online in the Journal of Clinical Oncology. These results supported the May 2020 U.S. Food and Drug Administration (FDA) accelerated …

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Bristol Myers Squibb Announces Exclusive Global License for Dragonfly’s IL-12 Investigational Immunotherapy Program

NEW YORK & WALTHAM, Mass.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) and Dragonfly Therapeutics, Inc. (“Dragonfly”), today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. DF6002 …

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Thermo Fisher Scientific Signs Oncology Companion Diagnostic Agreement with Hengrui Therapeutics

CARLSBAD, Calif., Aug. 17, 2020 /PRNewswire/ — Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Hengrui Therapeutics, Inc. (HTI), a U.S. subsidiary of Chinese pharmaceutical company Jiangsu Hengrui Medicine Co., Ltd. (JHM), to develop a CDx that will leverage the Oncomine Precision Assay, which runs on the …

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OneOncology and Foundation Medicine Unveil First-of-its-Kind Partnership to Advance Personalized Medicine at Community Oncology Practices

CAMBRIDGE, Mass. & NASHVILLE, Tenn.–(BUSINESS WIRE)–Foundation Medicine, Inc. and OneOncology today announced a new joint initiative that is intended to better enable OneOncology partner practice physicians to unlock the potential of precision oncology through comprehensive genomic profiling (CGP) and research, informed by CGP and real world evidence. This unique partnership will …

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FDA Accepts and Grants Priority Review to G1 Therapeutics’ NDA for Trilaciclib for Patients with Small Cell Lung Cancer

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and …

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