Eli Lilly has presented late-stage data which shows that a combination of Alimta and Roche’s blockbuster Avastin failed to improve overall survival of lung cancer patients.
Results from Phase III Pointbreak trial did not meet its primary endpoint of improved OS for patients with nonsquamous non-small cell lung cancer. About 930 patients were randomised to receive a combination of Alimta (pemetrexed) for injection) with Avastin (bevacizumab) and carboplatin induction followed by Alimta/Avastin maintenance compared to the combination of paclitaxel with Avastin and carboplatin followed by maintenance with the Roche drug.
Median OS for patients randomised to the Alimta arm was 12.6 months versus 13.4 months for paclitaxel arm, “a result that demonstrated no statistical difference,” said Lilly. However the firm noted that Pointbreak showed a statistically significant improvement in progression-free survival (6.0 months versus 5.6 months) in the Alimta arm. In terms of overall response and disease control rates, there was no difference between the two arms.
Allen Melemed, senior medical director with Lilly Oncology, said that Phase II results with this combination were promising and we were hoping to demonstrate an improvement in survival for nonsquamous NSCLC patients, so we are disappointed with the results”.
Alimta is a big earner for Lilly and had second-quarter sales of $659.5 million, up 8%. The drug is approved as first-line treatment in combination with cisplatin and as second-line and maintenance treatment of advanced lung cancer patients whose disease has not progressed immediately following platinum-based chemotherapy.
