Positive data from two studies of treating early breast cancer presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago showed progress is helping patients live longer. The primary endpoint data from the phase III Natalee study from Novartis AG showed that Kisqali (ribociclib), a CDK4/6 inhibitor, plus endocrine therapy (ET), for treating HR+/HER2-negative early breast cancer, compared to ET alone, reduced the risk of cancer recurrence by 25.2%. Eli Lilly and Co. also had good news, as fresh phase III study data showed two years of adjuvant Verzenio (abemaciclib) treatment, combined with ET, resulted in an invasive disease-free survival rate of 5.9% in patients ages 65 and older and 6.4% in patients younger than 65. The new data came from the phase III study of treating HR+/HER2-, node-positive, high risk early breast cancer at a high risk of recurrence.

ASCO 2023: Jazz’s HER2+ biliary cancer antibody outperforms chemo in phase II

HER2-targeting bispecific antibody zanidatamab, in development by Jazz Pharmaceuticals plc and Zymeworks Inc., produced better antitumor responses than current standard of care when used as a second line treatment for biliary tract cancer (BTC) in a pivotal phase IIb study, bringing it closer to becoming the first therapy to target HER2-expressing BTC. In the phase IIb Herizon-BTC-01 trial, the objective response rate (ORR; primary endpoint) among 80 patients with HER2-positive tumors was 41.3%, consistent, the company said, with top-line results released in December and more than double the 5 to 15% ORR seen with second-line chemotherapies.

ASCO-2023: Day One highlights updated pediatric glioma data at ASCO; rolling NDA underway

Impressive data continue to roll out for Day One Biopharmaceuticals Inc.’s tovorafenib in pediatric low-grade glioma, with results from 69 evaluable patients with relapsed or progressive disease showing a 67% overall response rate, as measured by Response Assessment for Neuro-Oncology High-Grade Glioma (RANO-HGG), with a 93% clinical benefit rate, in the phase II Firefly-1 trial. Those data, presented at the 2023 American Society of Clinical Oncology, will be included in a rolling NDA submission to the U.S. FDA, expected to be completed in October.

ASCO 2023: AI has little fad to it and a personalized future

Despite the title of the June 4 lead-off presentation at the American Society of Clinical Oncology (ASCO) meeting in Chicago, there was little room left for doubt about the increasingly important place of artificial intelligence (AI) in drug development. The program, Artificial Intelligence for Drug Development: Fad or Future, ultimately pointed to a positive future, with the only faddish part being discarded approaches that no longer work. It’s a future Dean Ho, head of the department of biomedical engineering at the National University of Singapore, said has taken 10 years of experience and data generation in order to build a modicum of trust among developers.

ITM grows supply network for ITM-11 with $240M financing round

ITM SE has closed a €225 million (US$240 million) round to prepare for market entry, as its lead targeted radiopharmaceutical ITM-11 nears the end of phase III development in the treatment of neuroendocrine tumors of gastroenteric or pancreatic origin (GP-NETs). “As we near the final stages of clinical development for ITM-11 in GEP-NETs, this substantial investment will help to further grow our supply network,” said Steffan Schuster, CEO. Munich, Germany-based ITM (Isotopen Technologien Munchen) will leverage the relationships it has built over the past 20 years of supplying 450 specialist cancer treatment centers with radioisotopes to market ITM-11 (177 Lutetium-edotreotide) itself.

Canbridge obtains the first approval for Alagille syndrome in China

Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 Livmarli (maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome (ALGS), a development that the company touted for how quickly it followed similar approvals elsewhere. “Livmarli is the first and only treatment approved for cholestatic pruritus from ALGS in the U.S., Europe and China,” a spokesperson told BioWorld. Livmarli is a minimally absorbed ileal bile acid transporter inhibitor that blocks the enterohepatic circulation of bile acids. It lowers bile acid levels in the liver and serum, reduces the resultant liver injury and relieves pruritus or extreme itching.

ASCO 2023: Weighing the advantages of emerging neoadjuvant therapies

An unexpected burst of early summer heat and three nights of Taylor Swift performances at nearby Soldier Field didn’t deter tens of thousands of cancer vaccine and therapy developers from swarming Chicago’s McCormick Place for the first full day of presentations at the American Society of Clinical Oncology (ASCO) meeting, one of the year’s biggest cancer conferences. On June 3, ASCO opened with fresh takes on newly emerging treatments of solid tumors using neoadjuvant immunotherapies. The morning’s eight abstracts prompted the nearly universal feeling that more research was needed but also provided doses of positive data into a treatment paradigm that is complex and little understood.

China increases anti-monopoly law enforcement in the biopharma industry

Anti-monopoly regulators in China are rebooting efforts to keep industries in check and may be zeroing in on the biopharma space. China’s State Administration for Market Regulation fined Grand Pharmaceutical Group Ltd. ¥136 million (US$19.68 million) and Wuhan Healthcare Pharmaceuticals Co. Ltd. ¥4.13 million for monopolistic behavior in the market for active pharmaceutical ingredients (APIs). Regulators also seized ¥149 million from Grand Pharma, saying it was “illegal gains” derived from a monopolistic deal with Wuhan Healthcare. This is one of the largest anti-monopoly fines of 2023.

The BioWorld Insider Podcast: Preventing opioid overdoses with a smart patch

Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

Also in the news

Ability, Affyxell, Alkeus, Alvogen, Ambrx, AOP Health, Athersys, Aurinia, Avacta, Avadel, Bioinvent , Biontech, Bluejay, Canbridge, Celltrion, Cero, Cerus, Connect, CSL Vifor, Cyclo, Daewoong, Erytech, Eli Lilly, Excision, Foghorn, Hemogenyx, Immodulon, Indivior, Innovent, ITM, Kyverna, Lotus, Medivir, Mesoblast, Neurogastrx, Neurotrauma, Novartis, Novavax, Novo Nordisk, NRX, Ocugen, Omeros, Oncoc4, Pfizer, Pherecydes, Phio, Rani, Rapid Dose, Realta, Replimune, RS, Scisparc, Selvita, Skye, Springworks, Synlogic, Teva, TG, Theratechnologies, TWI, Variant, Vaxequity, Vaxxas