Second in line for ESR1-mutant patients

In the oral oestrogen receptor degrader space Lilly has secured the industry's second approval, gaining FDA clearance for imlunestrant, which will be marketed as Inluriyo. Like Menarini's Orserdu, the first oral SERD to market, Inluryio is limited to patients with second-line ER-positive, HER2-negative breast cancer with ESR1 mutations. The restriction stems from the Ember-3 trial, which formed the basis of the approval but failed to demonstrate positive outcomes in the all-comer population. By contrast, Roche is hinting at broader success, recently reporting that its oral SERD giredestrant produced positive results in the second-line all-comer setting. But, with full data yet to be disclosed, questions linger over whether the effect is truly broad or still driven by ESR1m patients. Meanwhile, AstraZeneca is awaiting a regulatory decision for camizestrant in patients who develop ESR1 mutations during first-line treatment but before disease progression, with a PDUFA date set for the first half of 2026. Another degrader with a 2026 PDUFA date is Arvinas and Pfizer’s vepdegestrant. The asset failed to show benefit outside ESR1-mutant patients, and the companies appear to have little appetite to advance it further. Finally, Olema remains in the race but trails the frontrunners, with data due in the second half of 2026.

Pivotal oral SERDs in ER-positive, HER2-negative breast cancer

Source: OncologyPipeline.