Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone.
Novartis AG has had another setback in its attempt to get canakinumab to work in oncology, after the interleukin-1beta (IL-1β) inhibitor flunked a phase III trial in first-line advanced lung cancer.
DUBLIN – Oncopeptides AB has withdrawn its troubled multiple myeloma
drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA. The move comes less than a week before the FDA’s Oncologic Drugs Advisory Committee was due to consider the drug’s safety profile because of data anomalies that surfaced over the summer.
There’s a whole group of biotechs trying to create a tougher next-generation CAR T-cell therapy that could have a powerful effect on solid tumors after the technology’s first successes in blood cancer. One of those is London-based Leucid Bio Ltd., which has just raised £11.5 million (nearly US$16 million) in series A financing to develop next-generation CAR T therapies that are able to make it through to solid tumors and attack them.
Shares of Ultimovacs ASA (OSE:ULTI) climbed 16.6% to NOK148.60 (US$17.82) on news the FDA will expedite an eventual review of its investigational cancer vaccine, UV-1, in combination with checkpoint inhibitors for the potential treatment of unresectable or metastatic melanoma.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
Based on positive phase IIb data from 2020 for avasopasem manganese (GC-4419) in treating severe oral mucositis (SOM) in patients with locally advanced head and neck cancer, Galera Therapeutics Inc. had been confident about phase III data for the selective small-molecule dismutase. However, the phase III Roman trial failed to hit its primary endpoint of reduction in the incidence of SOM. Mel Sorensen, Galera’s CEO, expressed his surprise at the results and said the company is evaluating the next steps for the program.
Beigene Ltd., which in 2019 parlayed exclusive rights to distribute and promote Abraxane (paclitaxel) in China into more than $111 million in revenue, is contesting Celgene parent Bristol Myers Squibb Co.’s cancellation of the deal in arbitration proceedings at the International Chamber of Commerce.
Abbisko Cayman Ltd. has raised $226 million through an IPO in Hong Kong, where it launched with an initial price of HK$12.46 (US$1.60) per share. The company, doing business as Abbisko Therapeutics, plans to use about a third of the proceeds for research and development of its lead candidate, ABSK-091, a targeted inhibitor of fibroblast growth factor receptor subtypes 1, 2 and 3 intended as a potential treatment for multiple solid tumors, including urothelial cancer, gastric cancer, cholangiocarcinoma and lung cancer.
In trials name-checking some of the world’s highest peaks, longest rivers and most famous seas, Astrazeneca plc has long sought the best use of its CTLA4 inhibitor tremelimumab. Now, after a disappointing cruise along the first-line bladder cancer trial Danube and travails in non-small-cell lung cancer with the trials Mystic, Neptune and Arctic, a trek to the endpoint of its phase III trial Himalaya has yielded top-line success. A single, high priming dose of tremelimumab added to the company's immune checkpoint inhibitor, Imfinzi (durvalumab), led to a statistically significant overall survival (OS) benefit vs. Nexavar (sorafenib, Bayer AG and Amgen Inc.) in the first-line treatment for patients with unresectable hepatocellular carcinoma.
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