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Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Thursday, January 11, 2024
The BGB-11417-105 phase Ib/2 clinical trial aims to evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax in patients with relapsed or refractory multiple myeloma. Preliminary results demonstrate the combination of sonrotoclax and dexamethasone may be an efficacious treatment strategy, according to a presentation given at the 2023 American Society of Hematology (AHS) Annual Meeting & Exposition (Abstract 1011). From this study, the safety monitoring committee has recommended 640 mg as the phase II dose for this novel agent in further studies, explained Hang Quach, MD, FRACP, FRCPA, MBBS, of St. Vincent’s Hospital, Melbourne, Victoria, Australia, and colleagues.
Thus far, 19 patients with relapsed or refractory multiple myeloma that is t(11;14)-positive have been recruited for the study. Patients were assigned to dose-escalation cohorts to receive 80 mg (n = 3), 160 mg (n = 3), 320 mg (n = 3), or 640 mg (n = 10) of sonrotoclax daily and 40 mg of dexamethasone weekly. Patients were monitored regularly to assess for intolerability of treatment, disease progression, or death.
The study authors reported an overall response rate of 58% across all treatment cohorts, with a 70% response rate observed in patients receiving 640 mg of sonrotoclax. A partial response or better was achieved by 11 patients, with 1 patient achieving a complete response to treatment.
In addition, no treatment-related deaths have been reported. Moreover, grade 3 or higher treatment-related adverse events were reported by 16% of patients and included increased liver enzymes and diarrhea (n = 1), lymphopenia and hypokalemia (n = 1), and cataracts and retinal detachment (n = 1). Discontinuation of treatment because of adverse events was encountered in three patients, attributable to cancer pain (n = 1), COVID-19 infection (n = 1), and hematuria (n = 1).
“No patient, across all dose levels tested, experienced a dose-limiting toxicity,” stated Dr. Quach and colleagues.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2023 ASH Annual Meeting & Exposition
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