IDEAYA touts results for MAT2A inhibitorMAT2A inhibitor given a pass by GSK
08 Jul 2024
Clinical ResultADCPhase 1Phase 2
Shares of IDEAYA Biosciences jumped nearly 15% on Monday as the biotech unveiled promising Phase II data for IDE397, a potentially first-in-class MAT2A blocker for solid tumours. The study, focused on patients with urothelial and non-small-cell lung cancer (NSCLC) whose tumours harbour an MTAP deletion, demonstrated a 39% overall response rate (ORR), validating IDEAYA's decision to stick with the drug after GSK chose not to opt into the programme.
Loss of the MTAP tumour suppressor gene makes cells dependent on MAT2A, an enzyme that helps produce a key substance needed for cellular functions. IDE397 was designed to exploit this synthetic lethal vulnerability in MTAP-deficient tumoursMTAP-deficient tumours.
Among the study's 18 evaluable patients, who had undergone a median two prior lines of therapy, IDEAYA reported that there was one complete response (CR) and six partial responses (PRs), with two PRs awaiting confirmation. Five of the seven patients remain in response as of a June 21 cutoff date.
In addition, the disease control rate (DCR) reached 94%, with 14 out of 18 patients (78%) experiencing tumour shrinkage. The study also reported an 81% circulating tumour DNA (ctDNA) molecular response rate, with 13 out of 16 patients showing at least a 50% reduction in ctDNA. Median progression-free survival hasn't been reached yet.
The update demonstrates "important clinical proof-of-concept in MTAP-deletion solid tumours…and encouraging preliminary durability, with a convenient 30mg once-a-day tablet," according to CEO Yujiro Hata.
As for safety, the company said 5.6% of patients experienced Grade ≥3 drug-related adverse events (AEs), but no drug-related serious events or discontinuations. "We anticipate that the favourable AE profile and dosing convenience…has the potential to enable long-term dosing and combination development," IDEAYA added.
Peak sales of $1.2B
Mizuho Securities analyst Graig Suvannavejh estimates a peak of $1.2 billion in sales for IDEAYA in MTAP-deleted cancers.
IDEAYA and GSK had entered a partnership focused on synthetic lethality in 2020, which covered three of IDEAYA's programmes, including MAT2A, Pol Theta and Werner Helicase. However, GSK ended its research on the MAT2A inhibitorMAT2A inhibitor (also known as GSK4362676) in 2022, although the latter two programmes remain ongoing.
Aside from the current monotherapy trial, IDEAYA is also pursuing combination strategies for IDE397. The drug is in Phase I/II testing together with Amgen's second-generation PRMT5 inhibitor AMG 193 in NSCLC patients that is expected to complete in 2026. It is also in a Phase I study in combination with Gilead Sciences' Trop-2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan).
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