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September 01, 2016

Pfizer’s Medivation Deal Shakes Up Immuno-Oncology

Pharma Giant Seeks Cancer Leadership Position

Pfizer’s Medivation Deal Shakes Up Immuno-Oncology

Pfizer has sought to justify the deal as a faster path to the oncology leadership. [cancer.org]

  • Pfizer’s $14 billion deal for Medivation has begun shaking up immuno-oncology (I/O), and the ripple effects are affecting at least one other cancer immunotherapy developer.

    Pfizer has sought to justify the deal as a faster path to the oncology leadership that until now the pharma giant has only shown in flashes, such as with its successful breast cancer therapy Ibrance® (palbociclib).

    “The deal strengthens Pfizer's growing oncology franchise, and we remain confident in the company's wide moat” or competitive advantage over rivals, Morningstar analyst Damien Conover stated in a note to investors shared with GEN.

    Whether Pfizer achieves its cancer leadership dream will hinge in large part on its ability to build an I/O-focused portfolio combining immunotherapies with other cancer candidates usable in I/O combinations.

    Medivation brings Pfizer three potential tools toward I/O expansion. The most obvious is its blockbuster prostate cancer drug Xtandi® (enzalutamide). Its anti-androgen mechanism is technically immune stimulating, which could help Pfizer in trying cancer-fighting combinations that involve checkpoint inhibitors likeprogrammed cell death protein 1 (PD-1), Brad Loncar, CEO of Loncar Investments, told GEN. 

    “Those haven’t had much luck on their own in prostate cancer, so this is a natural combination one would look to,” Loncar said. “Pfizer will have to grow Xtandi sales quite a lot over time to make the economics of this deal work, so expanding the drug’s function in some way will be necessary.”

    Potential expansions could occur if Xtandi succeeds in three ongoing Phase III trials: PROSPER (vs. placebo in castration-resistant prostate cancer), EMBARK (with leuprolide in nonmetastatic hormone-sensitive prostate cancer [HSPC]), and ARCHES (with androgen deprivation therapy vs. placebo in metastatic HSPC).

    Medivation’s other I/O tools are pipeline candidates talazoparib (MDV3800), an oral poly(ADP ribose) polymerase (PARP) inhibitor, that is in a Phase III trial in breast cancer patients with a germline BRCA1/2 mutation, and pidilizumab (MDV9300), an antibody with immune-mediated antitumor effects. Medivation has planned to develop pidilizumab in diffuse large B-cell lymphoma and other hematologic malignancies, such as multiple myeloma. “Until it is further developed I wouldn't place much value on it,” Loncar said. “That being said, this is another asset Pfizer can use toward its combo strategy.”

    Pidilizumab joins a Pfizer roster of I/O candidates anchored by avelumab, a programmed cell death-ligand 1 (PD-L1) checkpoint inhibitor being developed through an up-to-$2.85 billion alliance with Merck KGaA. As of August 2, avelumab was in eight Phase III trials, the most recent one launching in July. JAVELIN Ovarian 100 (NCT02718417) is assessing avelumab with and/or following platinum-based chemotherapy in locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian cancer.

    Having outbid Sanofi and numerous other companies, reported to include AstraZeneca, Celgene, Gilead, and Merck & Co., Pfizer will have to develop Medivation’s pipeline without the executive who oversaw its development.

    Two days after the big deal came down, Amy Peterson, M.D., left Medivation for BeiGene, where she has been named CMO, Immuno-oncology. At BeiGene, she will oversee global clinical development of the PD-1 inhibitor BGB-A317, the PARP inhibitor BGB-290, and a growing I/O pipeline expected to enter clinical development.

    At least one firm appears intrigued by Dr. Peterson’s arrival: Zacks Investment Research upgraded its rating of BeiGene from “sell” to “hold” on August 26, two days after her hiring.

    Other recent I/O developments:

    • Novartis unit ends. Novartis is eliminating its Cell & Gene Therapies Unit by integrating its operations into the broader organization. Novartis restated its commitment to chimeric antigen receptor (CAR) T-cell research and its oncology portfolio, which will have 26 I/O studies by year’s end. Of those, six are potentially first-in-class as monotherapies and 11 are combination therapies.
    • Giant leap. Leap Therapeutics will acquire Macrocure in a deal intended to create a stronger I/O developer. The combined company will advance development of Leap’s two first-in-class cancer immunotherapies, lead development candidates DKN-01 and TRX518.
    • Opdivo OK. Ono Pharmaceutical won approval from Japan’s Ministry of Health, Labour, and Welfare for a third Opdivo® (nivolumab) indication, advanced renal cell carcinoma (RCC). The I/O treatment is also indicated for malignant melanoma and non-small-cell lung cancer (NSCLC).
    • Opdivo combo. Bristol-Myers Squibb (BMS) will supply Opdivo® (nivolumab) for a clinical study combining the I/O treatment with Bavarian Nordic’s CV301 in patients with previously treated NSCLC. Opdivo is approved for second-line NSCLC among other indications.

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