Olema Pharmaceuticals (OLMA) Jefferies London Healthcare Conference 2024 summary

Key data and clinical updates

• Palazestrant, an oral SERD and complete estrogen receptor antagonist, has shown promising monotherapy results, especially in ESR1 mutant breast cancer, with over seven months median PFS in later-line settings and over five months in wild type.

• Upcoming San Antonio Breast Cancer Symposium will present first-line combination data of palazestrant with ribociclib (Kisqali), including safety and efficacy in over 50 patients, with six months additional follow-up.

• Combination safety profile is favorable, similar to ribociclib plus letrozole, and allows full dosing of both agents without increased toxicity.

• Efficacy endpoints include clinical benefit rate (CBR) and six-month PFS, with RECIST criteria used for consistency and comparability.

• Patient population includes both CDK4/6-naive and previously treated individuals, enabling cross-trial comparisons.

Industry landscape and competitive analysis

• Multiple SERD and CDK4/6 combination studies are ongoing, including large phase II/III trials from Lilly (SERENA), Roche, and Arvinas/Pfizer, with key readouts expected in 2025–2026.

• Regulatory pathways are influenced by control arm selection; first-line labels require relevant comparators like CDK4/6 plus AI.

• Combination regimens may expand the market beyond current narrow labels (e.g., ORSERDU in ESR1 mutants) to broader second-line and wild type populations.

• Safety and tolerability remain differentiators, with some competitors showing high toxicity rates in combinations.

• Market opportunity for SERD/CDK4/6 combinations is estimated in the multi-billion dollar range, with significant unmet need in delaying chemotherapy.

Strategic and financial outlook

• Ongoing OPERA-01 phase III trial is fully funded for second/third-line monotherapy; first-line combination trial would require ~$500 million over five years, with half the cost attributed to drug supply.

• Advancement of the first-line trial is contingent on securing additional capital or partnerships; company will not proceed independently without full visibility on funding.

• Open to global partnerships or strategic M&A to access capital and maximize value, given the large addressable market and potential for significant upside.

• Additional pipeline asset, KAT6 inhibitor, expected to enter the clinic next year, partnered with Aurigene.