Relay Therapeutics Reports Positive Interim Results for RLY-2608

Relay Therapeutics Shares Update on RLY-2608 Progress

Relay Therapeutics Inc. has shared promising interim data for its investigational drug RLY-2608 from the ReDiscover study. This ongoing clinical trial focuses on evaluating the safety and efficacy of RLY-2608, both as a standalone treatment and in conjunction with fulvestrant, a commonly used breast cancer therapy. This study also includes exciting combinations with ribociclib, a CDK4 inhibitor developed by Pfizer Inc.

Encouraging Data from Heavily Pretreated Patients

The interim data revealed that patients suffering from PI3K?-mutated, HR+, HER2- locally advanced or metastatic breast cancer showed significant clinical progress. Despite undergoing extensive pre-treatment, those who received RLY-2608 at a dose of 600mg twice a day along with fulvestrant experienced clinically meaningful improvements in progression-free survival (PFS).

Statistical Highlights from the Study

According to the latest findings as of the August 12 data cut-off, several key statistics emerged from the cohort of 52 patients who met the qualifications:

Median Progression-Free Survival

The median PFS was noted to be 9.2 months across all mutations observed, with an increase to 10.3 months specifically among patients exhibiting kinase mutations.

Clinical Benefit Rate

The clinical benefit rate (CBR) attracted attention, marked at 57% for all patients, demonstrating a positive outcome for 20 out of 35 evaluable participants. CBR is typically defined by the proportion of patients who exhibit complete response, partial response, or stable disease for no less than 24 weeks.

Response Rates and Patient Outcomes

Delving deeper into the response rates, of the 30 patients assessed for measurable disease, a remarkable one-third secured a partial response, translating to an objective response rate (ORR) of 33%. Impressively, nearly three-quarters of the patients reported tumor reductions, with 73% showcasing significant progress through treatment.

Further Insights into Kinase Mutation Patients

A detailed analysis of the subset of 15 patients with kinase mutations revealed that over half achieved a partial response—53%, with 8 patients confirming their response, which adds further optimism towards the treatment's potential effectiveness.

Tolerability and Regulatory Pathway

Overall, RLY-2608 combined with fulvestrant exhibited favorable tolerability across the 118 patients treated so far. Meanwhile, Relay Therapeutics is in discussions with the FDA regarding the regulatory pathway for another compound, lirafugratinib, putting forth plans to submit a new drug application (NDA) while targeting a supplemental NDA for FGFR2 fusions.

Future Direction and Financial Health

Looking ahead, the company is dedicated to seeking a commercial partner for lirafugratinib while maintaining focus on developing its ongoing portfolio. As of the conclusion of the second quarter of 2024, Relay Therapeutics reported approximately $688 million in cash and cash equivalents, projected to sustain the company's operations through the latter part of 2026.

Stock Performance and Market Reaction

In light of these developments, RLAY stock has seen a significant rise, with a reported increase of 55.6% to $9.71 during the latest trading session. This surge indicates investor confidence in Relay Therapeutics' innovative treatment strategies and potential market impact.

Frequently Asked Questions

What is RLY-2608?

RLY-2608 is an investigational drug developed by Relay Therapeutics, targeting specific mutations in breast cancer.

What were the findings of the ReDiscover study?

The ReDiscover study demonstrated clinically meaningful progression-free survival for patients treated with RLY-2608, especially in those with specific mutations.

How well was RLY-2608 tolerated by patients?

RLY-2608 showed favorable tolerability in the patients treated, indicating a positive safety profile.

What is the company's future focus?

Relay Therapeutics aims to pursue a commercial partnership for lirafugratinib while advancing its existing portfolio.

What financial position does Relay Therapeutics hold?

As of the second quarter of 2024, Relay Therapeutics had approximately $688 million in cash, which is expected to support operations until 2026.

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