Deutsche Bank Discusses CDK4/6i Inhibitors in Treatment of Metastatic Breast Cancer (PFE) (LLY)

Deutsche Bank analyst Gregg Gilbert discussed CDK 4/6 inhibitors in the treatment of metastatic breast cancer with an oncologist at a leading US cancer center. The report noted that the physician offers Pfizer's (NYSE: PFE) Ibrance to most 1st-line MBC patients who are eligible for treatment with letrozole. The ability to use the drug in other settings was said to be very difficult.

"While the doctor acknowledged that treatment with Ibrance is cumbersome (lab tests to monitor neutropenia, insurance pre-approval), she starts most letrozole patients concurrently on Ibrance. Over the course of up to a year of treatment with Ibrance combination therapy, none of her patients have experienced any serious adverse events requiring hospitalization. She has seen some mouth sores and fatigue," said Gilbert. "She notes that while she does not doubt that Ibrance is an active drug, it is difficult to assess how the real-world efficacy compares to that seen in the clinical trial. She has not been 'wowed' by the clinical effect."

The analyst continued, "While this physician has not had significant experience with the other CDK 4/6i, we believe based on our discussion that there may be significant patient populations with unmet need for whom other CDK 4/6i in development as monotherapy (LLY’s abemaciclib, Phase 2) or in combination with other aromatase inhibitors (NVS’s ribociclib/exemestane, Phase 2 and LLY’s abemaciclib/anastrozole, Phase 2) may be used."

Gilbert added, "We note several key catalysts are expected in 2016 including interim readouts for LLY’s Phase 3 MONARCH 2 and 3 trials, top-line data and potential regulatory submission based on the Phase 2 MONARCH 1 trial as monotherapy for pre-treated HR+/HER2- MBC, interim readout of NVS’ Phase 3 MONALEESA-2 trial, and regulatory action on PFE’s Ibrance sNDA for label expansion to include treatment with fulvestrant in the US, and EU approval decision."

Deutsche Bank models global 2016 Ibrance sales of of $1.6 billion, with growth to $5.3 billion in 2020. For Eli Lilly & Co.'s (NYSE: LLY) abemaciclib, he models launch in 2018, with sales ramping to $1 billion by 2020.

Deutsche Bank has a Buy rating on Pfizer and Eli Lilly.

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