Pfizer Reveals Final Phase III Data On Inotuzumab Ozogamicin

Pfizer Inc. (NYSE:PFE) announced final data from the phase III study (INO-VATE ALL or Study 1022) on inotuzumab ozogamicin for the treatment of adults with relapsed/refractory acute lymphoblastic leukemia (ALL).

The open-label, randomized study evaluated the safety and efficacy of the candidate, in comparison to investigator-choice chemotherapy, in adults (n=326) with relapsed or refractory CD22-positive ALL.

The study had two primary endpoints – complete response with or without hematologic remission and overall survival (OS). Data from the study revealed an improvement over chemotherapy on a number of measures that included complete hematologic remission and progression-free survival (PFS). The study met its first primary endpoint of complete response, but failed to reach statistical significance in its second primary endpoint. However, the second primary endpoint of OS demonstrated a strong trend toward longer OS.

Results were published in the The New England Journal of Medicine. Moreover, updated data on OS were presented at the annual meeting of the Congress of the European Hematology Association.

We note that inotuzumab ozogamicin has Breakthrough Therapy designation in the U.S. for ALL.

Moreover, Pfizer, with its partner Merck & Co. Inc. (NYSE:MRK) , announced results from two phase III studies (VERTIS Mono and VERTIS Factorial) on ertugliflozin for the treatment of patients with type II diabetes.

Ertugliflozin (5 mg and 15 mg daily) was evaluated as monotherapy in the VERTIS Mono study, while the VERTIS Factorial study evaluated the co-administration of the candidate with Merck’s diabetes drug, Januvia.

Results from the studies demonstrated statistically significant reductions in A1C (a measure of average blood glucose) for both ertugliflozin doses tested. Data were presented at the Scientific Sessions of the American Diabetes Association.

The companies have expanded the VERTIS CV study to enable testing for superiority in improving CV outcomes in patients with type II diabetes. They plan to submit New Drug Applications in the U.S. for ertugliflozin and the two fixed-dose combination tablets – ertugliflozin/Januvia, and ertugliflozin/metformin – by 2016 end.

Pfizer currently sports a Zacks Rank #1 (Strong Buy). Bristol-Myers Squibb Company (NYSE:BMY) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) are two other favorably placed stocks in the health care sector, carrying the same Zacks Rank as Pfizer.