Talazoparib Tosylate

Pfizer has announced positive overall survival (OS) results from a late-stage study of its prostate cancer combination treatment. The phase 3 TALAPRO-2 trial has been evaluating the drugmaker’s PARP inhibitor Talzenna (talazoparib) in combination with its Astellas-partnered androgen receptor pathway inhibitor (ARPI) Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer (mCRPC). Results showed a statistically significant and clinically meaningful OS improvement for patients receiving the combination in the ‘all-comers’ cohort, as well as those with homologous recombination repair (HRR) gene-mutated mCRPC, compared to Xtandi alone. Talzenna plus Xtandi is now the first and only PARP inhibitor/ARPI combination to significantly improve survival in mCRPC patients regardless of mutation status, noted Roger Dansey, Pfizer’s chief development officer, oncology. The clinically meaningful improvement in radiographic progression-free survival from the prior primary analysis of the trial was also maintained in both cohorts, and the safety profile of the combination was generally consistent with the known safety profile of each drug. Prostate cancer is the second most common cancer in men worldwide, with an estimated 1.4 million new cases diagnosed in 2022. Up to 20% of patients develop mCRPC, a form of the disease that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to lower testosterone, within five to seven years of diagnosis. Talzenna plus Xtandi was approved by the US Food and Drug Administration in June 2023 for use in adults with HRR gene-mutated mCRPC. The combination was also approved by the European Commission in January 2024 to treat mCRPC in adults for whom chemotherapy is not clinically indicated. The new data from TALAPRO-2 will now be shared with global health authorities to support potential label expansion. Global lead investigator for the trial Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, said: “These OS results indicate potentially practice-changing efficacy for Talzenna in combination with Xtandi for men with mCRPC. “mCRPC is the most advanced and aggressive stage of the disease, and the TALAPRO-2 results provide much-needed hope to patients who remain in high unmet need for effective treatment options.”

Today, a brief rundown of news from Roche and Turnstone Biologics, as well as updates from Sanofi, Pfizer and Flagship Pioneering that you may have missed.Turnstone Biologics will lay off about 60% of its workforce and trim its pipeline in a bid to focus on a cancer cell therapy program in human testing, the company announced Friday. Through the restructuring, Turnstone will deprioritize preclinical work and put resources into a cell therapy in a Phase 1 trial for a variety of solid tumors. An update on the study is expected next year, while the restructuring moves will enable Turnstone to operate through the second quarter of 2026. Turnstoneraised $80 million in an initial public offering last year, but shares have lost nearly all of their value since. Ben FidlerThe Food and Drug Administration on Thursday approved a new Roche drug for breast cancer.Called Itovebi, the drug has been cleared for use with PfizersIbrance and endocrine therapy in people whose HR-positive, HER2-negative breast tumors have a mutation called PIK3CA. Itll compete for market share with Novartis Piqray, another medicine targeting PIK3CA mutations.Itovebi is one of five drugs Roche aims to add to its portfolio of breast cancer treatments, which already includes the targeted therapies Herceptin, Perjeta and Kadcyla. Jonathan GardnerVaccine developer Gritstone bio has filed for bankruptcy. The company said Thursday its in discussions with a party that would act as a potential buyer or plan sponsor, and should have some kind of deal ironed out as early as next week. The disclosure comes just weeks after Gritstone tapped the investment bank Raymond James to be its financial adviser as the biotech evaluated potential value-maximizing strategies. Earlier this year, the company laid off a significant portion of its employees and, shortly after, received disappointing results from a key study of its experimental vaccine for colorectal cancer. Jacob BellDenali Therapeuticssaid in a regulatory filingThursday that partner Sanofi has stopped a Phase 2 trial testing one of the biotechs experimental drugs in multiple sclerosis after the therapy missed its main and secondary study goals. The drug, oditrasertib, is part of a broad partnership Denali and Sanofi signed in 2018 to develop treatments for autoimmune and neurological diseases. It previously failed a study in ALS. Delilah AlvaradoA dual regimen of PfizersTalzenna and Xtandi helped people with advanced prostate cancer live longer than those who received Xtandi alone in a clinical trial, regardless of whether they had certain genetic alterations believed to be associated with a stronger benefit, the company said Thursday. The FDA last year approved the Talzenna-Xtandi combinationonly for people with these genetic signatures because of concerns over the safety and effectiveness of so-called PARP inhibitors like Talzenna in a broader population. Its issued similarly narrow clearances to Merck & Co. and AstraZenecas Lynparza and Johnson & Johnsons Akeega. With the new results, though, Pfizer now seeks to expand use of Talzenna. Jonathan GardnerPaul Parker is joining Flagship Pioneering as a managing partner, where hell oversee the biotechnology startup creators fundraising activities and manage its relationships with investors, the firm announced Thursday. Parker, who who previously served in top roles within the mergers and acquisitions groups of Goldman Sachs, Barclays Group and Lehman Brothers, is now Flagships third managing partner along with Doug Cole and Stephen Berenson. His appointment comes three months after Flagship raised $3.6 billion in additional capital and announced more than a dozen promotions and new hires to its leadership team. Gwendolyn WuThe FDA has turned back an experimental hypoglycemia drug from Zealand Pharma for the second time in less than a year. In a statement Tuesday, Zealand said the agency didnt approve the therapy, dasiglucagon, because of the timing related to the re-inspection of a third-party manufacturing facility. An initial examination of the facility uncovered deficiencies unrelated to Zealands drug, but nonetheless led the FDA to reject dasiglucagon in December. The re-inspection took place in August and September, but the manufacturer, which Zealand didnt name, hasnt yet received a positive recommendation. Delilah Alvarado '