Pfizer presented phase 2 trial data for its investigational lung cancer drug lorlatinib at the 18th World Conference on Lung Cancer in Japan Monday, showing a response rate as high as 90 percent.
The study on 275 patients with ALK+ and ROS1+ advanced non-small cell lung cancer (NSCLC) showed an overall response rate (ORR) of 90 percent (27 out of 30 patients) in treatment naïve ALK+ positive patients, the company said.
The ORR in ALK+ patients previously treated with Pfizer’s Xalkori (ingredient: crizotinib) – the current standard of care – was 69 percent, while the ORR in ROS1+ patients regardless of prior treatment was 36 percent, the company said.
“We are very encouraged by the results of this Phase 2 trial that provide the first clinical evidence of the activity of lorlatinib in this setting,” said Mace Rothenberg, chief development officer of oncology at Pfizer Global Product Development.
Lorlatinib is an investigational, next-generation tyrosine kinase inhibitor that aims to become the improved version of Xalkori. The U.S. FDA has designated the investigational drug Breakthrough Therapy status for those with ALK+ NSCLC previously treated with other drugs.
“Xalkori (crizotinib) was the first drug approved for patients with ALK-positive and ROS1-positive NSCLC. By understanding the mutations that occurred in patients that rendered their tumors resistant to Xalkori and other ALK inhibitors, we were able to design a molecule with the potential to overcome that resistance,” Rothenberg added.
Side effects were also “generally tolerable” with the most common adverse reaction being high cholesterol (81 percent), high triglycerides (60 percent), edema (43 percent) and peripheral neuropathy (30 percent), among others.
This is good news for Pfizer as Roche’s lung cancer therapy Alecensa (ingredient: alectinib) had proven efficacy over Pfizer’s Xalkori not once but twice this year. Roche Korea also announced its ALK+ NSCLC drug gained insurance coverage in Korea, making it more accessible and affordable for Korean ALK+ NSCLC patients.
Pfizer said it plans to discuss the data with regulatory authorities and is currently enrolling patients for its phase 3 test – CROWN – that is also taking place at designated Korean medical institutions.
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