Eli Lilly and Company (NYSE: LLY) announced final results of the Phase III PROCLAIM trial that will also be discussed in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. PROCLAIM was a randomized, Phase III superiority study of patients with locally-advanced, nonsquamous non-small cell lung cancer (NSCLC), which evaluated Lilly's ALIMTA® (pemetrexed for injection), in combination with cisplatin with concurrent radiation followed by maintenance ALIMTA in comparison with etoposide and cisplatin plus concurrent radiation, followed by consolidation chemotherapy of the oncologist's choice.
PROCLAIM was the largest study to evaluate the effect of pemetrexed/platinum plus radiation in this setting. Lilly announced in 2012 that the study enrollment was halted because an Independent Data Monitoring Committee projected that the experimental arm of the study would not meet its primary endpoint of superior overall survival. As no new safety issues were identified, all patients who received treatment with the pemetrexed regimen were allowed to continue their assigned therapy at the discretion of the investigator and were followed for survival with the final results now at ASCO.
"Despite the outcome of this trial, ALIMTA is approved in first-line, maintenance, and second-line therapy for people with advanced, nonsquamous non-small cell lung cancer," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We remain committed to exploring other combinations to treat patients with non-small cell lung cancer, including studying ALIMTA with some of the new immuno-oncology therapies in development."
In the PROCLAIM trial, patients with nonsquamous NSCLC were treated in the first-line setting with pemetrexed plus cisplatin and concurrent thoracic radiation therapy (n=283) or etoposide plus cisplatin and concurrent radiation (n=272). Patients on the pemetrexed arm received subsequent treatment with additional doses of single-agent pemetrexed and patients on the etoposide arm received consolidated chemotherapy – either more etoposide-cisplatin or vinorelbine-cisplatin or paclitaxel-carboplatin – as selected by the treating oncologist.
Those treated on the pemetrexed arm achieved a median overall survival (OS) of 26.8 months as compared to 25 months for those treated on the etoposide arm (HR 0.98; 95% CI: 0.79, 1.20; p=0.831). Median progression-free survival (PFS) was 11.4 months on the pemetrexed arm versus 9.8 months on the etoposide arm (HR 0.86; 95% CI: 0.71, 1.04; p=0.130) and an overall response rate (ORR) of 35.9 percent on the pemetrexed arm and 33 percent on the etoposide arm. Grade 3/4 adverse events occurred in 64.0 percent of patients on the pemetrexed arm with 76.8 percent on the etoposide arm. Grade 3/4 neutropenia/granulocytopenia was lower on the pemetrexed-cisplatin arm compared to the etoposide-arm (24.4% vs. 44.5%; p<0.0001), as well as rates of pneumonitis/pulmonary infiltrates (1.8% vs. 2.6%) and esophagitis (15.5% vs. 20.6%).