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 ( IDYA ).

“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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