Eli Lilly Phase III POINTBREAK trial fails to meet primary endpoint

9th September 2012 (Last Updated September 9th, 2012 18:30)

Eli Lilly and Company has reported that the Phase III POINTBREAK trial failed to meet its primary endpoint of improved overall survival in patients with nonsquamous non-small cell lung cancer (NSCLC).

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Eli Lilly and Company has reported that the Phase III POINTBREAK trial failed to meet its primary endpoint of improved overall survival in patients with nonsquamous non-small cell lung cancer (NSCLC).

The study randomised NSCLC patients to receive a combination of ALIMTA (pemetrexed for injection) with bevacizumab (AVASTIN) and carboplatin induction followed by ALIMTA plus bevacizumab maintenance, the ALIMTA arm, compared to the combination of paclitaxel with bevacizumab and carboplatin followed by bevacizumab maintenance, the paclitaxel arm.

The Phase III POINTBREAK trial has also failed to meet one of its secondary endpoints of improved progression-free survival for the ALIMTA arm.

Lilly Oncology senior medical director Dr Allen Melemed said the company was hoping to demonstrate an improvement in survival for nonsquamous NSCLC patients.

"POINTBREAK did show an improvement in progression-free survival, though this did not translate to an overall survival advantage," Melemed said.

Overall survival for patients randomised to the ALIMTA arm achieved a median overall survival of 12.6 months versus 13.4 months for patients on the paclitaxel arm, a result that demonstrated no statistical difference.

POINTBREAK showed a statistically significant improvement in progression-free survival (6.0 months versus 5.6 months [HR 0.83; p=0.012]) in the ALIMTA arm.

The study's secondary objectives of overall response rate and disease control rate failed to show difference between the two arms.

According to the study data, pre-specified non-comparative survival analysis for a subgroup of patients treated with maintenance therapy showed a median survival of 17.7 months for the ALIMTA arm, and 15.7 months for the paclitaxel arm and progression-free survival of 8.6 months and 6.9 months. Toxicity profiles differed between regimens.


Image: Eli Lilly POINTBREAK Phase III study did not meet primary endpoint. Photo: Courtesy of Guanaco152003.