DCC-3116 is a first-in-class inhibitor of autophagy.
(SAN ANTONIO) September 16, 2022 –– Dr. Anthony Tolcher, CEO and founder of NEXT Oncology, returned from the European Society for Medical Oncology (ESMO) in Paris, France, where he presented the findings of a phase I, first-in-human study that evaluates DCC-3116 alone and in combination with MAPK pathway inhibition in patients with MAPK pathway mutant locally advanced or metastatic solid cancers.
At the June 9, 2022, data cutoff, no dose-limiting toxicities, or serious treatment-emergent adverse effects (TEAEs) were reported. Additionally, the disease control rate at week 16 was 29% among 14 response-evaluable patients, with the best overall response being stable disease. The ULK1/2 inhibitor DCC-3116 was well tolerated as a monotherapy at doses ranging for 50 mg to 300 mg twice daily orally in 28-day cycles.
“DCC-3116 is a first-in-class, potent, and selective small molecule switch-control kinase inhibitor of ULK1/2,” Dr. Tolcher said during the presentation on September 10. “In preclinical models, it potently inhibits the proximal substrates ATG13 and ATG14 and blocks autophagy. In preclinical studies, when it is combined with a number of different MAP kinase pathway inhibitors, it leads to either additive or synergistic antitumor activity.”
In the 18-patient safety population, the most common TEAEs of any grade included fatigue (39%), dehydration (22%), increased alanine transaminase (ALT; 17%), and anemia (17%). No grade 4 TEAEs or deaths related to DCC-3116 were reported. There were 2 instances of asymptomatic, reversible increased ALT of grade 3 that led to a dose interruption and a dose reduction, respectively.
“Once again NEXT has been selected to perform groundbreaking studies and present the results,” Dr. Tolcher said. “The initial DCC-3116 monotherapy results reported today are very encouraging and strongly support the advancement of DCC-3116 into the combination setting. This is the first-in-class inhibitor of autophagy, which is a hot area in oncology.”
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About NEXT Oncology
NEXT Oncology is dedicated to the development of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them and are looking for their next option. NEXT is partnered with Texas Oncology, the largest private oncology practice in the United States with more than 400 referring oncologists and US Oncology, a network of independent, community-based oncologists in the U.S. This formidable size and reach provide NEXT unprecedented opportunities to transform what has come to be expected from clinical trials of new agents.