Sorrento announces positive phase IIa study results of abivertinib for the treatment of r/r marginal zone lymphoma and its plan for a pivotal phase III study.
The phase IIa study of abivertinib from Sorrento Therapeutics for r/r Marginal Zone Lymphoma, a rare type of B cell lymphoma, was conducted in China in 27 R/R MZL patients. Abivertinib showed significant treatment benefits in 27 patients who were relapsed or refractory after multiple lines of treatment with an ORR of 59.3% (11.1% CR and 48.2% partial responses).
This ORR is higher than the ORR of Ibrutinib (46%), which was first approved for the treatment of r/r MZL. The DCR was 92.6% and to date, both PFS and DOR have not been reached.
In the phase IIa study, abivertinib was well-tolerated, and no severe bleeding, arrhythmia (atrial fibrillation/flutter) or hypertension were seen in these abivertinib-treated patients. Given these early results, abivertinib has a promising safety and efficacy profile to date, which has the potential for it to be preferable to the approved drug Ibrutinib.
Sorrento has communicated with the NMPA, and a consensus has been reached for a pivotal phase III registration study for the treatment of R/R MZL.
The pivotal study will be a multicenter phase III study to assess the efficacy and safety of Abivertinib for treatment of relapsed/refractory marginal zone lymphoma. Sorrento will continue communicating with the NMPA to finalize the phase III protocol.
“We are very encouraged by the significant positive results of abivertinib for the treatment of R/R MZL, which would be a second indication of aAbivertinib for cancer treatment in addition to the potential treatment of resistant EGFR mutant positive non-small cell lung cancer" said Dr. Henry Ji, Ph.D., Chairman and CEO of Sorrento.
Though Sorrento is currently under Chapter 11 bankruptcy protection in the US, and based on prior experience with the drug in lung cancer, it will likely need US data to secure FDA approval.
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