Roche's Itovebi Approved for Breast Cancer; Turnstone Biologics Restructures

Key Insights

• The FDA approved Roche's Itovebi, inavolisib, for HR-positive, HER2-negative breast cancer with PIK3CA mutation, to be used with Pfizer’s Ibrance and endocrine therapy.
• Turnstone Biologics is restructuring, laying off 60% of its workforce to focus on a Phase 1 cancer cell therapy program for solid tumors, with updates expected next year.
• Pfizer's Talzenna combined with Xtandi showed prolonged survival in advanced prostate cancer patients, regardless of genetic alterations, seeking expanded use.

The FDA has approved Roche's Itovebi (inavolisib) for use in combination with Pfizer’s Ibrance (palbociclib) and endocrine therapy for patients with HR-positive, HER2-negative breast cancer harboring a PIK3CA mutation. This approval marks a new option for patients with this specific type of breast cancer, offering a potential alternative to Novartis’ Piqray (alpelisib), which also targets PIK3CA mutations.

Roche's Expanding Breast Cancer Portfolio

Itovebi is part of Roche's strategy to expand its breast cancer treatment options. The company already markets Herceptin, Perjeta, and Kadcyla. The approval of Itovebi provides another targeted therapy for a subset of breast cancer patients, addressing a specific genetic mutation that drives tumor growth.

Turnstone Biologics Restructuring

Turnstone Biologics is undergoing a strategic restructuring, which includes laying off approximately 60% of its workforce. The company will focus on its cancer cell therapy program currently in a Phase 1 trial for solid tumors. Turnstone anticipates providing an update on this study next year. The restructuring aims to extend the company’s operational runway through the second quarter of 2026.

Pfizer's Talzenna and Xtandi Combination

Pfizer announced positive results for the combination of Talzenna (talazoparib) and Xtandi (enzalutamide) in advanced prostate cancer. The clinical trial demonstrated that the combination prolonged overall survival compared to Xtandi alone, irrespective of specific genetic alterations. This finding could lead to an expansion of Talzenna’s approved use, which is currently limited to patients with certain genetic signatures due to prior safety and efficacy concerns with PARP inhibitors.

Other Notable Developments

Gritstone bio has filed for bankruptcy following disappointing results from a key study of its experimental vaccine for colorectal cancer. Denali Therapeutics, in partnership with Sanofi, reported that its Phase 2 trial of oditrasertib in multiple sclerosis failed to meet its primary and secondary endpoints. Additionally, the FDA has rejected Zealand Pharma’s dasiglucagon for congenital hyperinsulinism for the second time due to issues related to a third-party manufacturing facility.