Dive Brief:
- Novartis reported that advanced breast cancer patients using its proposed CDK 4/6 inhibitor drug LEE011 (ribociclib) combined with Femara (letrozole) reduced the progression of the disease or death by 44% over letrozle alone, and reduced tumor shrinkage of at least 30% with at least half the women studied. The findings were reported over the weekend from the European Society of Medical Oncology conference in Copenhagen, Sweden.
- Results from the pivotal Phase 3 MONALEESA-2 trial show LEE011 plus letrozole significantly extended progression-free survival (PFS) compared to letrozole, as first-line treatment in postmenopausal women with hormone receptor positive, human epidermal factor receptor-2 negative (HR+HER2-) advanced or metastatic breast cancer.
- The findings may propel Novartis with its CDK 4/6 inhibitor to challenge other drugs in the field, especially Pfizer’s leading blockbuster cancer drug Ibrance (pabociclib), although analysts indicated it is still a longshot for the Swiss company to overtake the giant U.S.-based Pfizer, noting some questions about safety in the clinical trials.
Dive Insight:
The latest demonstration from Novartis’ CDK4/6 inhibitor shows once again it may be inching closer to better compete with Pfizer’s blockbuster inhibitor Ibrance in the $4 billion breast cancer market, but it may still not be there.
There’s still no doubt, however, that Novartis’ ribociclib is likely to play a bigger role in the company’s pipeline and give it a chance to have a bigger part of the $4 billion breast cancer market. Pfizer has had a first-to-market advantage, although, both Novartis and Eli Lilly have claimed that their respective CDK 4/6 inhibitors are best-in-class. Sales of Pfizer’s Ibrance were enhanced by strong results in the PALOMA-2 study presented in April.
Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012, including 464,000 new cases in Europe that year. Up to one third of patients with early stage breast cancer may subsequently develop metastatic breast cancer, the most serious form of the disease, which occurs when the cancer has spread to other parts of the body, such as liver, brain and bones.
The Novartis Phase 3 MONALEESA-2 study improved PFS across all patient subgroups regardless of disease characteristics or demographics, the company said.
The results show that the combination "would be a major addition to the treatment options these patients have," said Gabriel N. Hortobagyi, of the University of Texas MD Anderson Cancer Center and MONALEESA-2 principal investigator.
In May, the company announced that a late-stage clinical trial of the drug was stopped early due to overwhelming efficacy. Novartis has been granted Breakthrough Therapy designation by the Food and Drug Administration.
Jefferies analysts said MONALEESA-2 showed the Novartis drug combination had "a marginally better efficacy result than Pfizer’s Ibrance, but its safety was more mixed, such as higher rates of mild GI events, and more serious but infrequent incidents of raised liver enzymes and QTc prolongation."
While Novartis’ data were impressive, "we believe Pfizer’s Ibrance has a good chance to retain leadership in CDK class," Evercore ISI analyst John Scotti said in a note to investors.