Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population.
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
Epidermal growth factor receptor (EGFR), when overactive or overexpressed, may lead to tumor growth and spread, and is thus a robust target for therapy.
Formosa Pharmaceuticals Inc. and Almac Discovery Ltd. have announced a global licensing agreement for development and commercialization of ALM-401, a first-in-class engineered bispecific antibody-drug conjugate (ADC) for the treatment of solid tumors characterized by the dual expression of EGFR and ROR1.
ALX Oncology Holdings Inc. has received FDA clearance for the IND application for ALX-2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors.
Black Diamond Therapeutics Inc. is getting $70 million up front and could earn up to $710 million in milestone payments in a deal with Servier for phase I-stage BDTX-4933, a small-molecule candidate targeting both RAS mutations and RAF alternations for treating solid tumors, including non-small-cell lung cancer.
Glioblastomas (GBMs) are the most malignant brain tumors and remain uncurable. Even after therapy, some glioblastoma stem cells (GSCs) survive in the brain parenchyma and cause tumor recurrence.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
