
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 climbed 8%, 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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