
Olema hedges its first-line bets

Olema, lagging in the estrogen degrader race, got a boost on Tuesday from a deal with Pfizer, under which the biotech will study its CERAN/SERD palazestrant in combination with Pfizer’s CDK4 inhibitor atirmociclib in first-line breast cancer. This is only a clinical trial agreement, but Olema’s stock closed up 18%, likely on hopes that Pfizer might want more; the big pharma recently ditched Arvinas’s rival project vepdegestrant in the front line, and might hand it back entirely. However, Olema investors have been down this road before. Many have long hoped for a takeout by Novartis, whose CDK4/6 inhibitor Kisqali was previously the favoured partner for palazestrant; however, a clinical trial agreement with Novartis last December is so far the best Olema has mustered. The Pfizer deal raises questions about which drug palazestrant could ultimately be combined with. The first-line Opera-02 trial, featuring Kisqali and once expected to begin in 2024, still hasn’t started. And Olema said a new 35-patient phase 1/2 trial, testing palazestrant plus atirmociclib, would “inform [a] potential pivotal” front-line study. Meanwhile, Roche is set to report data with its SERD giredestrant, in combination with Pfizer’s Ibrance, in first-line breast cancer this year.
Key palazestrant trials in ER-positive, HER2-negative breast cancer
Trial | Setting | Regimen | Note |
---|---|---|---|
Ph3 Opera-01 | 2nd-line | Monotx vs Faslodex or aromatase inhibitor | Data due H2 2026 |
Ph3 Opera-02 | 1st-line | + Kisqali, vs Kisqali + letrozole | To start Oct 2025 (delayed from YE 2024 & then “mid-2025”) |
Phase 1b/2 study | Undisclosed, assumed 1st-line | + atirmociclib | To start H2 2025 |
Source: OncologyPipeline & clinicaltrials.gov.
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