Roche announced Thursday interim results from a Phase II study showing that the experimental immunotherapy MPDL3280A reduced the risk of death by 53 percent in patients with previously treated non-small-cell lung cancer (NSCLC) whose cancer expressed the highest levels of PD-L1 compared with docetaxel. Chief medical officer Sandra Horning remarked that "the amount of PD-L1 expressed by a person's cancer correlated with improvement in survival."
The POPLAR trial included 287 patients with previously treated, advanced NSCLC and has a main goal of overall survival, with secondary endpoints including progression-free survival and overall response rate (ORR). Roche noted an improvement in survival was also observed in people who had medium and high or any level of PD-L1 expression. "The greater the expression of PD-L1, the greater the benefit," Horning remarked, adding "that's what exciting to us - seeing this biology that we've been studying really intently playing out in the clinic."
In February, MPDL3280A received breakthrough therapy status from the FDA for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments. Roche is currently conducting three Phase II and six Phase III studies of MPDL3280A in various kinds of lung cancer.
In addition, Roche announced Thursday positive results from two pivotal studies demonstrating that alectinib shrank tumours in people with advanced ALK-positive NSCLC whose disease had progressed following treatment with Pfizer's Xalkori (crizotinib). Horning said "we plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on [Xalkori]."
In the two studies, which included a combined total of 225 patients, alectinib was associated with ORRs of 50 percent and 47.8 percent. In addition, the drug, which inhibits ALK, was associated with ORRs of 57.1 percent and 68.8 percent in the two trials in people whose cancer had spread to the central nervous system. Meanwhile, results demonstrated that people whose tumours shrank in response to alectinib continued to respond for a median of 11.2 months and 7.5 months in the two studies.
"Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease," commented Horning. Alectinib was granted breakthrough therapy status by the FDA in 2013 for people with ALK-positive NSCLC whose disease progressed on Xalkori. Last year, alectinib was launched in Japan under the name Alecensa, where it is marketed by Chugai Pharmaceutical.
Data from all of the studies will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
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