Abstract discussant Hiroaki Akamatsu, MD, PhD, of Wakayama Medical University, Japan, highlighted the promising efficacy data supporting iruplinalkib, a highly selective, oral inhibitor of ALK and ROS1, in patients with ALK-positive non–small cell lung cancer (NSCLC).

“The efficacy profile is very similar to brigatinib in vitro, and in the clinical phase II trial, for patients with crizotinib-resistant ALK-positive NSCLC, the overall response rate was 70%, and the median progression-free survival was 19.8 months,” said Dr. Akamatsu. “These are very promising data.”

Hiroaki Akamatsu, MD, PhD

In the INSPIRE phase III trial, which enrolled an ALK inhibitor–naive patient population, iruplinalkib showed a superior median progression-free survival of 27.7 months, Dr. Akamatsu continued, and “the common adverse events were [aspartate transaminase/alanine transaminase] elevation and [creatine phosphokinase] increase, so [iruplinalkib] seems to be very safe.”

Despite superior efficacy to crizotinib and comparable safety vs other tyrosine kinase inhibitors, however, Dr. Akamatsu noted that iruplinalkib has not been compared with newer ALK inhibitors and may not, therefore, be considered a new standard of care for this patient population.

“I didn’t know much about the approval situation in China, but I would say that a new option does not always mean the new standard,” Dr. Akamatsu concluded. “Considering the limited number of ALK-positive patients, a weaker control arm should be avoided.” 

DISCLOSURE: Dr. Akamatsu reported financial relationships with Amgen, AstraZeneca, Boehringer Ingelheim Japan, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, MSD, Nippon Kayaku, Novartis Pharma, Ono Pharmaceutical, Pfizer, Takeda Pharmaceutical, Taiho Pharmaceutical, and Janssen Pharmaceutical.