Novartis wraps LEE011 PhIII early, barrels toward Pfizer showdown

Novartis ($NVS) has wrapped its pivotal study of the CDK 4/6 drug LEE011 (ribociclib) early with the promising breast cancer data it was looking for. And now the pharma giant will take the next big step toward marketing approval and a showdown with rival Pfizer ($PFE) over a multibillion-dollar market.

Investigators are saving the full set of data for a review at a cancer meeting, but their independent data monitoring committee confirmed that an interim analysis showed the Phase III study had hit the primary endpoint for progression-free survival.

Novartis recruited 668 patients for the study, which matched LEE011 with letrozole in treatment-free postmenopausal women who had hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

Novartis will now pursue regulatory approvals which will pit it directly against Pfizer--which recently achieved a major success with its accelerated approval for palbociclib, sold as Ibrance. 

These drugs are the result of years of research work concentrating on a new way to throw a monkey wrench in an aberrant cell cycle involved in cell replication. Overactive CDK 4 and 6 helps the cancer to accelerate, and checking that activity can rein it back in. Getting the pioneering approval in the field marks one of the biggest successes Pfizer has had in years. 

Analysts expect big things of LEE011, with some peak sales estimates topping $2 billion.

Next up is Eli Lilly ($LLY), which achieved ”breakthrough" status for its CDK 4/6 drug abemaciclib, though the company looks like it may be late to the CDK 4/6 party. Analysts now want to see if Lilly can also vault toward an approval after the interim analysis, with a lot riding on how the data stack up in comparison. Analysts still see plenty of room for one of these drugs to come out on top, with the other two fighting it out for second place. And everyone will be looking for Lilly to highlight an update on its drug at ASCO in June.

The much smaller RTP-based G1 Therapeutics, meanwhile, just landed a $47 million round to pursue what it considers a next-gen treatment in the field.

"We are excited that these results validate our belief that LEE011 in combination with letrozole can be a beneficial treatment option for women diagnosed with HR+/HER2- advanced breast cancer," said Alessandro Riva, global head of oncology development and medical affairs for Novartis Oncology, in a statement.

This also comes a day after the Swiss drugmaker made public a surprise shakeup of its cancer business, as it announced major plans to split its pharma and oncology biz. Both units will have two new leaders after the surprise departure of Novartis' veteran pharma chief David Epstein, who announced yesterday that he will be leaving the company. 

- here's the release
- check out FiercePharma's take on the changes at Novartis