Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Chimera Bioengineering Inc. has been selected as the winner of the Asian Fund for Cancer Research's (AFCR) 2021 BRACE Award Venture Competition, contributing $500,000 as part of a recent $7.5 million capital infusion and bringing to $26 million the company’s total amount raised to date.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
South Korean companies Ubix Therapeutics Inc. and SK Biopharmaceuticals Co. Ltd. are partnering to develop targeted protein degradation cancer therapies.
Genequantum Healthcare Co. Ltd. will work with Aimedbio Inc. to co-develop an antibody-drug conjugate (ADC) to treat brain and other cancers, working toward an IND filing in 2023. Aimedbio will focus on antibody development, while Genequantum will work on linker-payload development. “Since we have a plan to market and sell the product globally, we will conduct a phase I clinical trial in the U.S., Australia, South Korea, and China as a priority,” Do-Hyun Nam, founder, chairman, and chief technology officer of Aimedbio, told BioWorld.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers.
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