Eli Lilly and Company recently announced that the results of the PROCLAIM Phase III trial will be presented during the Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, May 29th -June 2nd.
PROCLAIM was a Phase III randomized, superiority trial that evaluated the efficacy of Lilly’s ALIMTA (pemetrexed for injection), in combination with cisplatin with concurrent radiation followed by maintenance ALIMTA in patients with locally-advanced nonsquamous non-small cell lung cancer (NSCLC). This regimen was compared with etoposide and cisplatin treatment plus concurrent radiation, followed by consolidation chemotherapy, in patients suffering with the same malignancy.
In 2012, the company announced it had terminated patient enrolment, since an Independent Data Monitoring Committee considered the study’s experimental arm would not meet its primary endpoint: superior overall survival. Since there were no safety problems, all patients treated with pemetrexed continued their assigned treatment and were followed-up for survival.
“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 in a recent news release 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 study NSCLC patients received treatment with pemetrexed plus cisplatin and concurrent thoracic radiation therapy (n=283) or etoposide plus cisplatin and concurrent radiation (n=272).
Patients on the pemetrexed experimental arm were also treated with additional pemetrexed, while those on the etoposide experimental arm were treated with consolidated chemotherapy, with more etoposide-cisplatin, vinorelbine-cisplatin or paclitaxel-carboplatin.
The median overall survival (OS) was of 26.8 and 25 months for patients who recevied pemetrexed or etoposide, respectively.
Patients on the pemetrexed arm achevied a median progression-free survival (PFS) of 11.4 months in comparison with a PFS of 9.8 months observed in the group treated with etoposide. The overall response rate (ORR) was of 35.9% for those patients who received pemetrexed and of 33% for those patients administered with etoposide.
Adverse side events (grade ¾) occurred in 64% and 76.8% of patients who received pemetrexed or etoposide, respectively.