IDEAYA Biosciences Highlights 'Encouraging' Preliminary Efficacy, Safety Profile For Patients With Hard-To-Treat Cancer

Monday, IDEAYA Biosciences Inc IDYA released clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase-deletion urothelial and non-small cell lung cancer patients (NSCLC).

“IDE397 is a potential first-in-class MAT2A inhibitor, that is being advanced as a monotherapy agent in priority MTAP-deletion solid tumor types and in high conviction rational combinations, including with Amgen’s investigational MTA-cooperative protein arginine methytranferase 5 inhibitor AMG 193 in NSCLC and with Gilead’s Trop-2 directed anti-body conjugate Trodelvy in urothelial cancer,” said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.

“The IDE397 clinical data update demonstrates important clinical proof-of-concept in MTAP-deletion solid tumors to deliver RECIST responses and encouraging preliminary durability, with a convenient 30mg once-a-day tablet and favorable adverse event profile.”

The clinical data update in the eighteen (18) evaluable patients includes:

• ~39% Overall Response Rate (ORR), with one complete response and six partial responses.
• Two partial responses are awaiting confirmation, including one urothelial cancer patient who had a 100% tumor reduction in the target lesion at the last CT-scan assessment and one adenocarcinoma NSCLC patient.
• One complete response and two partial responses were urothelial cancer patients.
• Among patients with lung cancer, three partial responses were squamous NSCLC patients, and one partial response was an adenocarcinoma NSCLC patient.
• There was one non-evaluable patient who discontinued due to rapid clinical progression of cancer fatigue and drug-unrelated adverse events in cycle 1 of treatment.
• 94% Disease Control Rate and 78% of patients with tumor shrinkage. Fourteen (14) out of eighteen (18) evaluable patients observed tumor shrinkage.
• Median duration of treatment, median duration of response, and median progression-free survival not yet reached.
• 81% ctDNA Molecular Response (MR) Rate. Thirteen (13) of sixteen (16) patients had 50% or greater ctDNA reduction. Several quality control failures of patient samples led to the unavailability of MR analysis.
• Favorable adverse event profile was observed.

Price Action: IDYA shares are up 15.2% at $39.45 at last check Monday.

Image by PDPics from Pixabay

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