NEW YORK – Repare Therapeutics on Monday said the first non-small cell lung cancer patient has received its ATR kinase inhibitor camonsertib in a monotherapy expansion cohort of the ongoing Phase I/II TRESR trial.
In that study, Repare is evaluating safety, tolerability, and anti-tumor activity of camonsertib alone and in combination with Pfizer's PARP inhibitor Talzenna (talazoparib) or the chemotherapy gemcitabine in patients with advanced cancers whose tumors have ATR inhibitor sensitizing mutations. The investigators are also looking for biomarkers that correlate with camonsertib exposure and clinical outcomes.
In April 2023, Repare reported results from TRESR showing that treatment with camonsertib plus Talzenna or gemcitabine led to durable clinical benefit across tumor types with different genomic alterations and an overall clinical benefit rate of 48 percent.
In the monotherapy cohort, Repare investigators will enroll up to 20 patients with ATM-mutated NSCLC to receive camonsertib at the recommended Phase II dose.
"Our biomarker-driven approach with camonsertib monotherapy has the potential to address the high unmet need of over 5,000 patients with ATM-mutated NSCLC in the tumor recurrence setting across the US, UK, and top four EU markets where, unfortunately, the current standard of care provides progression-free survival of approximately four months and low response rates," Maria Koehler, Repare chief medical officer and executive VP, said in a statement.
Repare regained rights to camonsertib in February after Roche ended a collaboration agreement signed in June 2022 to develop and commercialize the drug worldwide. The Montreal-based company has several other cancer drugs in development. It is studying the PKMYT1 inhibitor lunresertib with Debiopharm's WEE1 kinase inhibitor Debio 0123 in the Phase I/Ib MYTHIC trial in tumors with certain mutations and in a Phase I trial as a monotherapy in biomarker-selected solid tumors. It is also testing the PLK4 inhibitor RP-1664 in a Phase I trial as a treatment for patients with advanced tumors bearing alterations in TRIM37 and other genes.