IDEAYA Biosciences (IDYA Quick QuoteIDYA - Free Report) announced positive clinical data from its mid-stage study evaluating the 30 mg monotherapy expansion dose of IDE397 to treat heavily pre-treated methylthioadenosine phosphorylase (MTAP)-deletion urothelial (bladder) and non-small cell lung cancer (NSCLC) patients. Shares of the company soared 15.3% on Jun 8 in response.

Management believes that theIDE397 study data demonstrates important clinical proof-of-concept in MTAP-deletion solid tumors to deliver meaningful responses and encourage preliminary durability of response with a convenient 30mg once-a-day tablet.

IDE397 is IDEAYA’s potent and selective potential first-in-class MAT2A inhibitor.

The phase II clinical data for IDE397, based on 18 evaluable patients with MTAP deletion, includes seven with urothelial cancer, four with adenocarcinoma NSCLC, and seven with squamous NSCLC. These patients were treated with the 30 mg expansion dose once a day.

The reported clinical efficacy and tolerability data are preliminary, drawn from an investigator-reviewed unlocked database as of the cutoff date of Jun 21, 2024.

Year to date, shares of IDEAYA have gained 11% against the industry’s 7.9% decline.

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Per the data readout, the study achieved an overall response rate of 39%.  Among the 18 evaluable patients, there was one complete response and six partial responses according to RECIST 1.1 evaluation. Two partial responses are pending confirmation, including a urothelial cancer patient with 100% tumor reduction and an adenocarcinoma NSCLC patient. The complete response and two partial responses were in urothelial cancer patients. Three partial responses were observed in squamous NSCLC patients and one in an adenocarcinoma NSCLC patient. One patient discontinued due to rapid disease progression and drug-unrelated adverse events.

A disease control rate of 94% was also observed in the study. Furthermore, 14 out of 18 evaluable patients (78%) experienced tumor shrinkage. Additionally, 13 out of 16 patients, who represented 81% of the evaluable patient population, experienced a ctDNA reduction of 50% or more. The IDE397 expansion dose of 30 mg achieved target drug coverage and plasma S-adenosyl-l-methionine pharmacodynamic reduction associated with preclinical tumor regressions.

IDEAYA reported that there were several quality control failures of patient samples that led to the unavailability of molecular response analysis. Also, at the time of the data readout, median duration of treatment, median duration of response, and median progression-free survival had not yet been reached.

The company also reported that the 30 mg once-daily expansion dose of IDE397 was overall well tolerated with a favorable safety profile. No serious adverse events or discontinuations due to the drug were observed. Per IDEAYA, such a safety profile and convenient dosing schedule suggest the potential for long-term use and combination therapy development.

The candidate is simultaneously being evaluated in combination with other approved drugs for NSCLC and urothelial cancer.

Currently, no FDA-approved therapies exist for patients with MTAP-deletion solid tumors, representing a significant unmet medical need. IDE397's phase II monotherapy program prioritizes bladder cancer and NSCLC, where MTAP-deletion prevalence is more than 15% and 25%, respectively. Per IDEAYA, the estimated annual incidence of MTAP-deletion in NSCLC and urothelial cancer in the United States is about 48,000 patients. Additional tumor types, such as pancreatic, gastric, esophageal and head and neck cancers, are being considered for further development, with pancreatic cancer showing more than 20% MTAP-deletion prevalence, affecting approximately 14,000 patients annually in the United States.

The company’s clinical-stage pipeline consists of two other investigational candidates, darovasertib (IDE196) and IDE161, which are being evaluated in separate studies for several cancer indications.

IDEAYA Biosciences, Inc. Price and Consensus

IDEAYA Biosciences, Inc. price-consensus-chart | IDEAYA Biosciences, Inc. Quote

Zacks Rank and Stocks to Consider

IDEAYA currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the drug/biotech industryare ALX Oncology Holdings (ALXO Quick QuoteALXO - Free Report) , Annovis Bio (ANVS Quick QuoteANVS - Free Report) and Compugen (CGEN Quick QuoteCGEN - Free Report) . Each stock presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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