Repare Therapeutics Presents Updated Clinical Data from the Ongoing Phase 1/2 TRESR Study of RP-3500 Monotherapy in Solid Tumors at the 2022 AACR Annual Meeting
Updated monotherapy results show 43% CBR in solid tumors across genotypes, and potential best-in-class safety and tolerability
Encouraging data in tumors harboring STEP2 genes, including BRCA1/2 mutations, where
Company to host conference call today at
“We see promising monotherapy data across tumor types, particularly in advanced ovarian cancer where 90% of patients had failed previous treatment with PARP inhibitors and platin based therapy. We are especially pleased with the 25% overall response observed, the clinical benefit rate of 75% and a median PFS of 35 weeks in this heavily pre-treated patient population with a growing unmet need,” said
The data were featured today at the AACR Annual Meeting in an oral presentation titled, “Genomic and pathologic determinants of response to
“The data presented today continue to demonstrate RP-3500’s promising clinical benefit given as monotherapy in patients with solid tumors with multiple genotypes, as predicted by our SNIPRx platform, as well as a potential industry-leading safety and tolerability profile for ATR inhibitors,” said
The Company will subsequently host a conference call today,
Key Initial Findings from the TRESR Phase 1/2 Study:
TRESR is a first-in-human, multi-center, open-label Phase 1/2 dose-escalation and expansion study, designed to establish the recommended Phase 2 dose (RP2D) and schedule, evaluate safety and pharmacokinetics and identify preliminary anti-tumor activity associated with
The oral presentation described monotherapy Phase 1 (Module 1) results from 120 patients, of which 99 patients were evaluable for efficacy, including 95 patients at RP2D of 160mg and schedule taken weekly for 3 days on/4 days off, and reflecting a data cutoff of 14th February, 2022. Key highlights from the data presented at the 2022 AACR Annual Meeting include:
RP-3500monotherapy continues to appear safe and well tolerated. Expectedly, Grade 1-2 anemia was the most common treatment-related adverse event and well controlled in patients. Only 24.2% of all patients in the 3 days on 4 days off schedule experienced Grade 3 anemia, and none Grade 4 anemia.
RP-3500monotherapy resulted in durable clinical benefit across tumor types and genomic alterations. Overall clinical benefit rate (CBR) for all patients was 43%, and 47% in patients after PARP inhibitor (PARPi) failure.
- Promising results were observed particularly in patients with advanced ovarian cancer (n = 20). 90% of evaluated patients had prior PARPi failure, and 85% of evaluated patients were platinum resistant. In these patients, overall response (OR) was 25%, including one complete response (CR), three partial responses (PR) as determined by RECIST 1.1 criteria, and one durable and ongoing CA125 response. CBR was 75% and median progression-free survival (mPFS) was 35 weeks.
- Clinical benefit was also observed in patients with tumors harboring BRCA1 and BRCA2 genomic alterations, as predicted by SNIPRx. In patients with BRCA1/2 mutated tumors (n = 37), ORR was 14% and included two patients with ovarian cancer, and one each with breast cancer, head and neck squamous cell carcinoma, and melanoma. CBR was 43% with a mPFS of 15 weeks in the BRCA1/2 population; in patients specifically with BRCA1 mutations, the CBR was 48%.
- In patients with ATM loss-of-function (LOF) tumors (n = 34), ORR was 9% including one RECIST 1.1 confirmed/unconfirmed response, and two prostate specific antigen (cPSA) responses. CBR in patients with ATM LOF was 44%, with mPFS of 17 weeks.
New sequencing data demonstrated biallelic gene LOF, an emerging biomarker for synthetic lethal therapies, can potentially be leveraged to further enrich for patients most likely to benefit from
RP-3500. CBR in patients with biallelic LOF was significantly higher (47%) compared to the CBR in patients with non-biallelic tumors (15%).
A second poster presentation titled, “Detection of biallelic loss of DNA repair genes in formalin-fixed, paraffin embedded (FFPE) tumor samples using a novel tumor-only sequencing panel with error correction” (abstract number 2801) will be presented on
Company Conference Call:
The Company will host a conference call with accompanying slides for analysts and investors today at
To access the call, please dial (877) 870-4263 (
About Repare Therapeutics’ SNIPRx® Platform
Repare’s SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
SNIPRx® is a registered trademark of
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical development of the Company’s pipeline and its research and development programs, including the anticipated timing, anticipated patient enrollment, trial outcomes or associated costs of its Phase 1/2 TRESR clinical trial of
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