During the American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, Eli Lilly and Company presented the final data of the Phase III PROCLAIM trial. This study compared the overall survival of patients with locally advanced, Stage III Non-Small Cell Lung Cancer with nonsquamous cell histology.
Non-Small Cell Lung Cancer (NSCLC) is any type of epithelial lung cancer besides small cell lung cancer (SCLC). The most frequent forms of NSCLC are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Although NSCLCs are associated with cigarette smoke, adenocarcinomas may be found in patients who have never smoked. NSCLCs are considerabley insensitive to chemotherapy and radiation therapy compared to SCLC.
The Phase III PROCLAIM trial was the largest randomized study of patients with locally-advanced, nonsquamous non-small cell lung cancer (NSCLC), treated with Lilly’s ALIMTA, pemetrexed for injection, combined with cisplatin and associated radiation followed by ALIMTA continuation. This treatment was compared with etoposide and cisplatin plus associated radiation, followed by consolidation chemotherapy chosen by the oncologist.
Dr. Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, said in the news release that regardless the results of this clinical study ALIMTA is approved as first-line, maintenance, and second-line treatment for individuals with advanced, nonsquamous non-small cell lung cancer. He added that they will continue to investigate other drug combinations for the treatment of individuals with non-small cell lung cancer, as well as evaluating ALIMTA with other novel immuno-oncology treatments under development.
In the PROCLAIM trial, patients with nonsquamous NSCLC were treated on a first-line setting with pemetrexed (a folate antimetabolite that prevents the formation of DNA and RNA,) plus cisplatin (a platinum-containing anti-cancer drug) along with concurrent thoracic radiation therapy or etoposide (a cytotoxic anticancer drug which belongs to the topoisomerase inhibitor drug class) together with cisplatin and radiation.
The overall response rate (ORR) in patients treated with pemetrexed and etoposide was of 35.95% and 33%, respectively. The grade 3/4 for neutropenia/granulocytopenia was significantly lower on the pemetrexed-cisplatin group when compared to the etoposide group (24.4% vs. 44.5%; p<0.0001). Also patients treated with pemetrexed-cisplatin had less pneumonitis/pulmonary infiltrates (1.8% vs. 2.6%) and esophagitis (15.5% vs. 20.6%).
Patients with locally advanced or metastatic, nonsquamous NSCLC are now prescribed as second-line therapy with ALIMTA after chemotherapy.