Lung cancer study showed encouraging results for ALIMTA-based regimens and full-dose radiation

Eli Lilly and Company (NYSE: LLY) announced results of a Phase II trial evaluating ALIMTA® (pemetrexed for injection) in combination with a platinum chemotherapy and radiation for patients with locally advanced non-small cell lung cancer (NSCLC). The findings will be presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. on June 4, 2012.

“The current standard of care for many patients facing this type of lung cancer is treatment with chemotherapy and radiation together,” said Hak Choy M.D., professor and chairman of radiation oncology at the University of Texas Southwestern Medical Center. “Yet, there is no true consensus on the chemotherapy regimens that can be combined well with full-dose radiation. It is our hope that these results begin to consolidate the choices an oncologist has to make when beginning treatment.”

The open-label randomized trial (ASCO Abstract #7002) evaluated 98 patients with inoperable stage IIIA/B NSCLC who were randomized one-to-one to receive either ALIMTA (500 mg/m(2)) plus carboplatin (AUC5) or ALIMTA (500 mg/m(2)) plus cisplatin (75 mg/m(2)) intravenously every 21 days for three cycles. All patients received concurrent radiation treatment (64-68 Gy [2 Gy/day for five days per week from days 1-45]). Three weeks after completion of radiation treatment, patients received consolidation treatment with ALIMTA (500 mg/m(2)) every 21 days for three cycles.

Patients treated on the ALIMTA+carboplatin+radiation arm achieved 18.7 months median overall survival (95% CI) for a two-year overall survival rate of 45.2% (95% CI, 29.3-59.8 months). Those treated on the ALIMTA+cisplatin+radiation arm achieved 27.0 months overall survival (95% CI) for a two-year overall survival rate of 57.6% (95% CI, 41.6-70.7 months).

Median time to disease progression was 8.8 months for those treated on the ALIMTA + carboplatin + radiation arm compared to 13.1 months for those treated on the ALIMTA + cisplatin + radiation arm.

Patients treated on the ALIMTA+carboplatin+radiation arm achieved 52.2% overall response rate (6.5% with a complete response, 45.7% with a partial response). Results of those treated on the ALIMTA+cisplatin+radiation arm found an overall response rate of 46.2% (3.8% with a complete response, 42.3% with a partial response).

Grade 4 toxicities reported on both arms of the study included anemia, neutropenia, thrombocytopenia and esophogitis. No drug-related deaths were reported.

These Phase II results support the ongoing Phase III study, PROCLAIM, which is studying the overall survival of patients with locally advanced nonsquamous NSCLC when treated with ALIMTA and cisplatin given at the same time as radiation followed by consolidation ALIMTA.

Reference

1. World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/lungcancerlow.pdf, (April 20, 2011).
2. American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” December 16, 2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (April 20, 2011).
3. American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” October 20, 2009, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (April 20, 2011).

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