Results of phase III INO-VATE ALL study of PF 5208773 (inotuzumab ozogamicin) in acute lymphoblastic leukemia published in New England Journal of Medicine- Pfizer

Pfizer has announced the publication of findings from the Phase III INO-VATE ALL study of PF 5208773 (inotuzumab ozogamicin) in acute lymphoblastic leukemia, in the online issue of The New England Journal of Medicine. The study, also known as Study 1022, is an open-label, randomized, Phase III study evaluating the safety and efficacy of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL). Results showed improvement over chemotherapy on a number of measures including complete hematologic remission and progression-free survival (PFS).

INO-VATE ALL met its first primary endpoint of complete response, which was significantly better with inotuzumab ozogamicin compared to chemotherapy (80.7% vs. 29.4%). Inotuzumab ozogamicin also significantly extended PFS compared to chemotherapy (median PFS, 5.0 vs. 1.8 months, in their respective arms). The second primary endpoint of OS showed a strong trend toward longer OS for patients treated with inotuzumab ozogamicin compared to chemotherapy, but did not reach the level of statistical significance for the trial (median OS, 7.7 months vs. 6.7 months ).

The two-year OS rate for inotuzumab ozogamicin was 23 percent compared to chemotherapy at 10 percent. Updated results and newly available overall survival data were also presented as a late-breaking oral presentation at the 21st Congress of the European Hematology Association.

See: "Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia" Hagop M. Kantarjian et al. NEJM online June 12, 2016 DOI: 10.1056/NEJMoa1509277