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12:00 AM
 | 
Jun 10, 2013
 |  BioCentury  |  Product Development

O-ver and above

Potency key as obinutuzumab, Arzerra try to best Rituxan in CLL

Freshly unveiled data for obinutuzumab from Genentech Inc. and Roche and for Arzerra ofatumumab from GlaxoSmithKline plc and Genmab A/S showed similar progression-free survival relative to standard of care in chronic lymphocytic leukemia patients who are not candidates for highly toxic chemotherapy. While Arzerra may hold a small edge in safety, the signals so far are unlikely to be differentiating factors.

Data from the Roche sponsored CLL11 trial presented last week at the American Society of Clinical Oncology meeting provided the first Phase III data comparing obinutuzumab (GA101) plus chlorambucil to Rituxan rituximab plus chlorambucil and to chlorambucil alone, and specifically in a CLL population selected for unfitness.

GSK and Genmab did not present Arzerra CLL data at ASCO, but late last month released top-line Phase III data for their drug in unfit CLL patients.

Six doctors reached by BioCentury would not call either next-generation anti-CD20 mAb either superior to Rituxan or ready to replace the drug without seeing more mature PFS or overall survival data. But several suggested higher rates of minimal residual disease seen with obinutuzumab vs. Rituxan could be predictive of a PFS or an OS advantage.

The CLL space

First-line standard of care depends upon a patient's age and health. Younger or more fit patients typically receive a combination of fludarabine and cyclophosphamide (FC) alone or with Rituxan (FCR).

In older patients with comorbidities, chlorambucil is SOC because FC has shown no major clinical benefit but additional toxicity compared to chlorambucil. This cohort accounts for 45-70% of treatment-naïve CLL patients based on estimates from Roche and one physician.

Rituxan from Roche and Biogen Idec Inc. is approved for CLL in combination with fludarabine and cyclophosphamide. It is used off label in combination with chlorambucil in unfit patients based on Phase II data that showed the mAb is active and well tolerated in elderly CLL patients. Those trials did not directly compare the combination to chlorambucil alone.

GSK markets Arzerra in the U.S. and EU to treat patients with CLL refractory to fludarabine and Campath alemtuzumab. The pharma has worldwide co-development and commercialization rights from Genmab.

Campath, a mAb against CD52 from Sanofi, is indicated as monotherapy in treatment-naïve B cell CLL. The pharma withdrew alemtuzumab from the U.S. and EU markets last year, but provides the drug free of charge to oncologists for CLL (see BioCentury, Aug. 27, 2012).

Both Arzerra and obinutuzumab are...

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