Drug Development

Best in class? Eli Lilly claims a lead role awaits its CDK 4/6 drug abemaciclib after PhIII success

Levi Garraway, Lilly

The pharma giant says their drug abemaciclib garnered promising data in an interim analysis of MONARCH-3, a breast cancer trial that matched their drug with either of two aromatase inhibitors — letrozole or anastrozole — against only the aromatase inhibitor. The full data will be rolled out later, with Lilly limiting itself to the boast that their drug has the potential to be the best-in-class therapy in the likely three-way struggle to come.

Investigators recruited women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Lilly had dropped well behind the two frontrunners with their broad and ambitious Phase III program. MONARCH 1 and MONARCH 2 data are being teed up to regulators at the FDA and EMA in this quarter, with the MONARCH 3 package being prepped for a Q3 delivery.

Lilly is racing to catch up with Novartis, which gained an approval for Kisqali (ribociclib) in March. And Pfizer scored the landmark approval in the field with Ibrance in 2015, helping that company achieve a noted advance in cancer drug R&D.

The primary endpoint of the Lilly study was PFS, with key secondary endpoints of ORR, overall survival and safety. And Seamus Fernandez at Lilly was pleasantly surprised by the interim success — particularly as an earlier trial had to run its full course before Lilly could claim a win.

This is an unexpected win for LLY, in our view, as we and most investors expected the trial to go to completion at its planned final analysis at the end of this year.

Analysts will be looking for the actual data to see how it measures up with rivals, particularly after Lilly managed to stun the biopharma world with news that the FDA had rejected baricitinib, widely expected to breeze through to an OK. Lilly has yet to explain what went wrong, which is not helping its R&D credibility after three straight failures for its lead Alzheimer’s drug solanezumab.

“Today marks another important milestone in our clinical development program for abemaciclib, a drug we believe has the potential to be best in class,” said Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology. “We are very excited about the results seen in patients with breast cancer, from single-agent activity to clinically meaningful benefit when used in combination with fulvestrant or aromatase inhibitors. Along with additional abemaciclib clinical trials in other tumor types, these data underscore Lilly’s commitment to delivering life-changing medicines to treat and cure people living with cancer around the world.”

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