I recently ran an article about a promising new lymphoma drug, brentuximab vedotin (SGN-35). Here are study results, just released to us from the ASH press room about bv:
Results of a Pivotal Phase 2 Study of Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma [Abstract 283]
While 70-80 percent of all newly diagnosed patients with adult Hodgkin lymphoma are typically cured with combination chemotherapy of three or four agents together, there still is a significant number of patients whose disease progresses after initial induction chemotherapy. For these patients, treatment options include additional courses of the same or different chemotherapy regimens followed by an autologous stem cell transplant. However, for patients whose disease returns after an autologous stem cell transplant, there currently are no approved treatment options.
A phase I study in 45 relapsed or refractory Hodgkin lymphoma patients (NEJM, Nov. 4 issue) found that more than half of the 28 patients treated at doses ranging from 1.2 mg/kg to 2.7 mg/kg of brentuximab vedotin achieved an objective (measurable) response. Brentuximab vedotin is an investigational antibody-drug conjugate that delivers a highly potent chemotherapy agent – monomethyl auristatin E – directly to Hodgkin lymphoma cells and induces cell death via an anti-CD-30 antibody.
Based on these phase I results, researchers led by the City of Hope National Cancer Center in California and The University of Texas M. D. Anderson Cancer Center enrolled patients into a phase II, single-arm, multicenter study that was designed to evaluate the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma who had already undergone an autologous stem cell transplant.
A total of 102 patients at 26 study centers across the United States received brentuximab vedotin (1.8 mg/kg) every three weeks as a 30-minute outpatient IV infusion for up to 16 cycles of treatment. The primary endpoint of the study was the overall objective response rate. Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival, and tolerability.
Similar to findings from the phase I study, tumor reduction was demonstrated in 96 patients (94 percent), and objective response rate was 75 percent. These findings were validated by an independent review committee. Thirty-four percent of patients achieved a complete remission, and median duration has not yet been reached. Brentuximab vedotin was generally well-tolerated in this patient population, with the majority of adverse events, including peripheral neuropathy, fatigue, and nausea, being grade 1 or 2.
“The responses seen in these heavily pre-treated and refractory patients suggest that, if approved by the Food and Drug Administration, brentuximab vedotin may become an important treatment option for patients with relapsed or refractory Hodgkin lymphoma,” said Robert Chen, MD, Assistant Professor, City of Hope National Medical Center in California. “Additionally, other studies are currently underway to determine if brentuximab vedotin, when used in combination with standard chemotherapy, will also improve outcomes in newly diagnosed patients, potentially changing the treatment paradigm for Hodgkin lymphoma.”
So much more to report I don’t know where to begin! Much more tomorrow.
Feel good and keep smiling! Pat