Lilly gets positive abemaciclib phase 3 data, plots 2017 NDA

Lilly can only hope to be third to market after rivals Pfizer and Novartis.

Eli Lilly was hit earlier this month when rival Novartis became the second, after front-runner Pfizer, to gain FDA approval for its CDK 4/6 inhibitor Kisqali (ribociclib), but a readout from its new phase 3 data has buoyed the Big Pharma nonetheless, as it plots an NDA in Q2.

The data, from the late-stage Monarch 2 trial, combined abemaciclib with AstraZeneca’s marketed Faslodex (fulvestrant) in women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer who have relapsed or progressed after endocrine therapy.

Full details were not released, but the top-line data from the near 700 patients showed that the combo therapy created a statistically significant improvement in progression-free survival (PFS) when pitted against AZ’s med with a dummy drug. Exact numbers will be “presented at an upcoming medical meeting,” Lilly said in a statement.

This comes after a small hiccough last year when the study was not stopped early. It was briefly paused for an independent Data Monitoring Committee (DMC) to assess its survival numbers, but at the time, the DMC said the study could go on “without modification as the interim efficacy criteria were not met.”

The Big Pharma would have liked to have seen the trial stop early, but today’s results will likely prove good enough for the company.

The drug, which has an FDA breakthrough tag, is slated to submit an NDA to the agency in the second quarter, based on the Monarch 1 phase 2 data out last summer, as well as an additional app for its Monarch 2 data in Q3.

The NDA on Monarch 1 will be for the treatment of refractory metastatic breast cancer patients whose disease had progressed following multiple prior treatments, including endocrine therapy and one to two chemotherapy regimens in the metastatic setting.

Lilly is some way behind rival Pfizer, which has already seen its competing med Ibrance (palbociclib) approved by the FDA, with Novartis also gaining a very recent FDA nod for its med, making Lilly likely third to market in this potential blockbuster arena.

Along with Monarch 1 and 2, Lilly currently has three additional trials testing abemaciclib in breast cancer, including a late-stage trial of abemaciclib in combination with a nonsteroidal aromatase inhibitor in patients with HR+, HER2- loco-regionally recurrent or metastatic breast cancer.

Analysts at Barclays said in a note to clients: “Lilly did not disclose specific details on Monarch 2, but we believe that the data could make the upcoming ASCO meeting in June. From an efficacy perspective, we anticipate that the focus will be on both the absolute and relative PFS benefit, with market leader Ibrance in the PALOMA-3 trial showing a median PFS of 9.2 months vs. 3.8 months for fulvestrant.

“From a safety perspective, the top question will inevitably be targeted on diarrhea rates in abemaciclib arm, which has been the top investor concern on abemaciclib, followed by neutropenia rates, which are a systemic issue for the CDK 4/6 class. Lilly characterized the adverse events as consistent with prior abemaciclib studies, which could require co-use of loperamide and monitoring though this is widely known already.”