Inotuzumab Ozogamicin Plus Bosutinib May Be Safe, Effective for Relapsed/Refractory ALL and CML

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Eleven patients had a complete response: 10 had complete cytogenic remission, 8 were negative by flow cytometry, 6 had undetectable BCR-ABL. Three patients did not respond.
Eleven patients had a complete response: 10 had complete cytogenic remission, 8 were negative by flow cytometry, 6 had undetectable BCR-ABL. Three patients did not respond.
The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

Inotuzumab ozogamicin with bosutinib is a safe, tolerable, and potentially effective treatment for patients with Philadelphia chromosome–positive relapsed or refractory acute lymphoblastic leukemia (ALL) or chromic myeloid leukemia (CML) in blast phase, according to interim results of a study being presented at the 2017 American Society of Hematology (ASH) annual meeting in Atlanta, Georgia.1

Despite therapeutic advances, patients with relapsed/refractory ALL or CML in blast phase have poor outcomes. In this setting, ALL exhibits high CD22 expression, which is inhibited by inotuzumab ozogamicin.

For this phase 1/2 study (ClinicalTrials.gov Identifier: NCT02311998), researchers evaluated the safety and efficacy of inotuzumab ozogamicin in combination with bosutinib, a tyrosine kinase inhibitor approved for blast-phase CML, among patients with relapsed/refractory ALL or CML.

Of 14 patients enrolled and treated, 12 had ALL and 2 had blast-phase CML; the median age was 62 years. One dose-limiting toxicity was observed with bosutinib 400 mg daily; none were observed with bosutinib 300 mg daily. Dose-limiting toxicity evaluation is ongoing for bosutinib 500 mg daily.

Eleven patients had a complete response: 10 had complete cytogenic remission, 8 were negative by flow cytometry, 6 had undetectable BCR-ABL. Three patients did not respond.

The median event-free survival was 8.1 months; the median overall survival was 8.2 months. Four patients are still in remission after allogeneic hematopoietic stem cell transplantation.

The authors added that once the maximum tolerated dose is established, phase 2 will begin.

Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.

Reference

  1. Jain N, Cortes JE, Ravandi F, et al. Inotuzumab ozogamicin in combination with bosutinib for patients with relapsed or refractory Ph+ ALL or CML in lymphoid blast phase. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.

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