Roche Advances Obesity Drug Trial and Receives FDA Decision Date for Breast Cancer Therapy
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
Roche Holding AG announced positive results from a phase II clinical trial of petrelintide, an amylin analog being developed to treat overweight and obesity. The trial showed that petrelintide achieved up to 10.7% mean body weight reduction at week 42. The company reported no vomiting or gastrointestinal-related treatment discontinuations at the maximally effective dose of petrelintide.
Separately, the Food and Drug Administration will decide by December 18 whether to approve the company's experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications.
Roche's submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the "adjuvant" setting after surgery.
If approved, giredestrant would become the third new oral SERD on the market, following clearances for Menarini Group's Orserdu and Eli Lilly's Inluriyo.
The company enrolled a total of 373 people in the evERA trial and randomized them to take an older drug called everolimus alongside either giredestrant or traditional hormone therapy. Those who got giredestrant had a 44% lower relative risk of dying or having their disease progress. Among people with mutations to a gene called ESR1 — an alteration that occurs during or after exposure to hormone therapy — the relative risk was 62% lower.
Oral SERDs have so far only been approved for use in people with ESR1 mutations. If approved, giredestrant would join them. Roche expects to submit data supporting use in the adjuvant setting "in the coming weeks" and also has a late-stage study underway in frontline breast cancer. Results from that trial are expected in the first half of 2026.
The drug may become "the new backbone of choice" for ER-positive, HER2-negative tumors that represent the majority of breast cancer cases, the chief executive of Roche's pharmaceuticals division said on a conference call with analysts last month. The executive noted how Roche is pursuing "many combinations" involving giredestrant and other in-house medications.
For the obesity program, Roche said it plans to begin a phase II trial combining petrelintide with CT-388 later in 2026.