88% total response price (15 out of 17) from interim information of pan-FGFR remedy (FGFRi)-naïve FGFR2-fusion cholangiocarcinoma (CCA) sufferers handled at the pivotal dose
Enrollment for the pivotal cohort anticipated to be accomplished within the second half of 2023
Relay Therapeutics to host a convention name on Monday, September 12, at 8:00 am E.T.
CAMBRIDGE, Mass., Sept. 11, 2022 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY) immediately introduced late breaking interim scientific information in an oral presentation for RLY-4008, an investigational, potent, selective and oral small molecule inhibitor of fibroblast development issue receptor 2 (FGFR2), in a worldwide section 1/2 scientific trial in sufferers with FGFR2-altered CCA and a number of different stable tumors. The interim information offered immediately at the European Society for Medical Oncology (ESMO) Congress reveal an 88% total response price (ORR) at the pivotal dose of RLY-4008, 70 mg as soon as day by day (QD), as of August 1, 2022, and additional assist our speculation that selective inhibition of FGFR2 can enhance the remedy for sufferers with FGFR2-driven tumors.
“We are thrilled to be sharing interim RLY-4008 data from patients treated at the pivotal dose with the ESMO community,” mentioned Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “We believe the interim ORR of 88% for these patients helps to demonstrate the potential power of our Dynamo platform to build transformative therapies for patients. Additionally, we continue to generate clinical data outside of CCA and anticipate sharing them in 2023. Beyond RLY-4008, we have a robust pipeline of precision medicine candidates, and we look forward to next presenting initial clinical data on our pan-mutant-selective PI3Kα inhibitor, RLY-2608, expected in the first half of 2023. Thank you to the patients, investigators and clinical trial teams who participate in clinical trials of our investigational therapies.”
Key Data Presented at ESMO Congress 2022
The information offered at the ESMO Congress have been based mostly on an August 1, 2022 information closing date from each the dose escalation and dose enlargement phases of the trial. The interim information included a security database of 195 sufferers, with 89 sufferers handled at the pivotal dose of 70 mg QD, of which 17 have been FGFRi-naïve FGFR2-fusion CCA sufferers eligible for efficacy analysis (sufferers with measurable illness who had alternative for ≥2 tumor assessments to verify response or discontinued remedy with <2 tumor assessments).
- 15 out of 17 of the efficacy evaluable sufferers at the pivotal dose skilled a partial response leading to an 88% interim ORR (14 confirmed, 1 unconfirmed in an ongoing affected person).
- 13 out of 15 responders stay on remedy; 1 responder got here off examine to be resected with healing intent.
- The two sufferers with finest response of secure illness stay on remedy.
- More broadly throughout all dose ranges and schedules, 38 FGFRi-naïve FGFR2-fusion CCA sufferers have been eligible for efficacy analysis, of which 24 skilled a partial response leading to a 63% interim ORR (22 confirmed, 2 unconfirmed).
The interim security evaluation as of the August 1, 2022 closing date was usually according to the evaluation from the June 2022 information disclosure:
- Most remedy emergent antagonistic occasions have been anticipated FGFR2 on-target, low-grade, monitorable, manageable and largely reversible.
- There have been no noticed Grade 4 or 5 antagonistic occasions.
- Off-target toxicities of hyperphosphatemia and diarrhea continued to be clinically insignificant.
The oral presentation from the ESMO Congress is obtainable on the Relay Therapeutics web site beneath Publications: https://relaytx.com/publications/.
Key Upcoming RLY-4008 Milestones
- The pivotal cohort of FGFRi-naïve FGFR2-fusion CCA sufferers is anticipated to be totally enrolled within the second half of 2023.
- Initial information from the non-CCA enlargement cohorts are anticipated to be offered in 2023.
- The entirety of the dose escalation information is predicted to be offered at a medical assembly or printed by the top of the primary half of 2023.
Conference Call Information
Relay Therapeutics will host a convention name and stay webcast on September 12, 2022 at 8:00 am E.T. Registration and dial-in for the convention name could also be accessed by means of Relay Therapeutics’ web site beneath Events within the News & Events part by means of the next hyperlink: https://ir.relaytx.com/news-events/events-presentations. An archived replay of the webcast will probably be out there following the occasion.
About RLY-4008
RLY-4008 is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that’s continuously altered in sure cancers. FGFR2 is one among 4 members of the FGFR household, a set of intently associated proteins with extremely related protein sequences and properties. Preclinically, RLY-4008 demonstrated FGFR2-dependent killing in most cancers cell strains and induced regression in in vivo fashions, whereas minimal inhibition of different targets was noticed, together with different members of the FGFR household. In addition, RLY-4008 demonstrated robust exercise in opposition to recognized scientific on-target resistance mutations in mobile and in vivo preclinical fashions. RLY-4008 is at the moment being evaluated in a scientific trial in sufferers with superior or metastatic FGFR2-altered stable tumors with a single arm, doubtlessly registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA. To study extra in regards to the scientific trial of RLY-4008, please go to right here.
ReFocus Trial Background
RLY-4008 is at the moment being evaluated in a worldwide section 1/2 scientific trial (ReFocus) in sufferers with FGFR2-altered CCA and a number of different stable tumors together with a single arm, doubtlessly registration-enabling cohort for FGFRi-naïve FGFR2-fusion CCA. The section 1 dose escalation has been accomplished, and 70 mg QD has been chosen because the registrational dose. The enlargement cohorts have been initiated in December 2021 and now encompass seven totally different cohorts based mostly on FGFR2 alteration and tumor sort. Of the seven cohorts, the potential pivotal cohort consists of roughly 100 beforehand handled, FGFRi-naïve FGFR2-fusion CCA sufferers.
About Relay Therapeutics
Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision drugs firm reworking the drug discovery course of by combining modern computational and experimental applied sciences with the objective of bringing life-changing therapies to sufferers. As the primary of a brand new breed of biotech created at the intersection of disparate applied sciences, Relay Therapeutics goals to push the boundaries of what’s doable in drug discovery. Its Dynamo™ platform integrates an array of modern computational and experimental approaches designed to drug protein targets which have beforehand been intractable. Relay Therapeutics’ preliminary focus is on enhancing small molecule therapeutic discovery in focused oncology and genetic illness indications. For extra info, please go to www.relaytx.com or observe us on Twitter.
Cautionary Note Regarding Forward-Looking Statements
This press launch comprises forward-looking statements inside the that means of the Private Securities Litigation Reform Act of 1995, as amended, together with, with out limitation, implied and categorical statements concerning Relay Therapeutics’ technique, business plans and focus; the progress and timing of updates on the scientific improvement of the applications throughout Relay Therapeutics’ portfolio, together with the timing of disclosures concerning further scientific information updates and enrollment for RLY-4008 and preliminary scientific information for RLY-2608; the anticipated therapeutic advantages of its applications, together with potential efficacy and tolerability; whether or not preliminary outcomes from our preclinical or scientific trials will probably be predictive of the ultimate outcomes of the trials or any future scientific trials of our product candidates; the chance that unconfirmed outcomes from these trials is not going to be confirmed by further information because the scientific trials progress; and Relay Therapeutics’ expectations referring to its present and future interactions with the U.S. Food and Drug Administration, together with its perception concerning a possible pivotal cohort. The phrases “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and related phrases or expressions are supposed to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases.
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