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AACR: Olaparib and pembrolizumab combination shows early promise in molecularly selected, tumor-agnostic trial

MD Anderson News Release April 27, 2025

• Combining Lynparza (olaparib) and Keytruda (pembrolizumab) showed antitumor activity in multiple cancer types, particularly those with BRCA1/2 mutations 
• In this combination trial patients were matched by genetic features, not tumor type ¨C a tumor-agnostic, molecularly matched trial that included 30 different cancer types 
• Prior studies indicated potential for synergy between these two therapies, and this study verified this in multiple advanced solid tumors, especially in certain subsets of patients 
•  Combination demonstrated complete responses and partial responses in different cancer types, including those beyond the currently approved indications for these therapies 

ABSTRACT:

The combination of the PARP inhibitor olaparib and the PD-1 inhibitor pembrolizumab showed initial antitumor activity with no new safety signals in a molecularly matched, tumor-agnostic trial, particularly in patients with BRCA1/2 mutations, according to results from a Phase II trial led by researchers at Â鶹ӳ»­ MD Anderson Cancer Center.

Data from the KEYLYNK-007 trial were presented today in the clinical trials plenary session at the by , professor of Investigational Cancer Therapeutics and vice president and head of clinical development in MD Anderson¡¯s Therapeutics Discovery division.

¡°Previous studies suggested this combination was likely to have synergistic effects, and that¡¯s what we saw in this trial,¡± Yap said. ¡°We demonstrated durable antitumor activity, particularly in the subset of patients with BRCA1/2 mutations across multiple different solid tumors, which goes beyond the currently approved indications for these therapies.¡±

The trial enrolled 332 patients with 30 different cancer types, according to three different genetic alteration groups defined in advance, including: patients with BRCA1/2 mutations, those with non-BRCA1/2 homologous recombination repair (HRR) mutations, and those with homologous recombination deficiency (HRD).

Eighteen patients had a complete response to this treatment as determined by radiological imaging, with 11 of them in the BRCA1/2 mutation subgroup. Responses were seen in multiple tumor types for which these therapies are not currently approved.

The safety profile was consistent with the known safety profiles of both therapies.

¡°It¡¯s notable that this trial represents the largest dataset of molecularly matched patients for this combination therapy,¡± Yap said. ¡°We hope further analysis of these data can help identify new predictive biomarkers to better identify patients likely to have exceptional responses to this combination.¡±

This trial was funded by Merck Sharp & Dohme. A full list of coauthors and their disclosures can be found in the abstract

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