|The following article features coverage from the American Society of Hematology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Combining the BRAF inhibitor vemurafenib with obinutuzumab in patients with relapsed or refractory hairy cell leukemia (HCL) resulted in a complete response rate of 100% in the frontline setting, with the majority of patients achieving minimal residual disease negativity, according to the results of a trial presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida.
Based on these results, the researchers concluded that this combination “appears to be a promising chemo-free targeted therapeutic approach for HCL.”
In the small study, 14 patients with previously untreated HCL were enrolled and assigned to vemurafenib 960 mg twice daily from month 1 to 4 and obinutuzumab from months 2 to 4. The median patient age was 49 years.
At median follow-up of 10.1 months, nine of the 14 patients completed all treatments and were evaluable for response. At the end of month 4, 8 patients had minimal residual disease-negative complete response.
The researchers found that 7 of 8 patients with a minimal residual disease-negative complete response had a previously undetectable BRAFV600E mutation, which was detected by highly sensitive digital polymerase chain reaction.
Eleven patients required dose reductions/interruptions due to AEs, most commonly due to rash, followed by arthralgia and pancreatitis. A majority of the patients had normalization of cytopenia within 4 weeks of starting therapy.
“A longer follow-up is needed to assess durability of remission and degree of immunosuppression compared to cladribine-treated cohorts,” the researchers wrote on their poster.
Enrollment in the study is ongoing at Memorial Sloan Kettering Cancer Center, Dan-Farber Cancer Center, and Yale.
Disclosure: Some of the authors disclosed financial relationships with the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.
Read more of Cancer Therapy Advisor‘s coverage of ASH’s annual meeting by visiting the conference page.
Park JH, Shukla M, Salcedo JM, et al. First line chemo-free therapy with the BRAF inhibitor vemurafenib combined with obinutuzumab is effective in patients with Hcl. Presented at: 61st American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 3998.