FDA accelerates BGB-16673 for CLL, SLL
According to BeiGene, the maker of the new drug, the Food and Drug Administration (FDA) will accelerate BGB-16673 for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) who have been previously treated with two or more therapies.
Key findings:
- The FDA is accelerating its review of BGB-16673, a novel drug to treat chronic lymphocytic leukemia and small cell lymphocytic lymphoma, both types of blood cancer.
- BGB-16673 is showing promising results in an ongoing study. Previous data showed that in 72% of patients the disease decreased or disappeared after treatment.
- The novel drug is taken orally and is a BTK inhibitor that works by interrupting a signaling pathway involved in cancer cell growth.
- Patients with CLL or SLL can still enroll in a Phase 2 trial testing BGB-16673.
The goal of the FDA’s Fast Track designation, according to the agency, is to speed up the development and review of drugs to treat serious diseases or conditions with unmet needs. The goal of the designation is to get these drugs to the patients who need them more quickly.
This accelerated trial – specifically for patients treated with a Bruton’s tyrosine kinase (BTK) and BCL2 inhibitor – is based on results from a Phase 1/2 trial presented at the European Hematology Association Congress in June. The trial is evaluating different doses of BGB-16673. Data from the ongoing trial, which has treated more than 300 patients to date, showed that BGB-16673 is well tolerated and has “promising efficacy” in heavily pretreated patients with relapsed or refractory CLL or SLL.
“As patients taking BTK inhibitors experience disease progression, given the central importance of this pathway in CLL/SLL, there is a need for BTK-targeted agents with a different mechanism of action. Knocking down BTK proteins with our BTK CDAC (BGB-16673) could address this unmet need,” said Mehrdad Mobasher, MD, Chief of Hematology at Beigene, in a company press release.
The study results showed that among patients with evaluable responses, the overall response rate (percent of patients whose disease decreased or disappeared) was 72%. The group that received the 200-milligram dose of BGB-16673 had the highest response rate, at 88%. These included two complete responses, meaning that all signs of cancer disappeared in two patients.
The data also showed that the median time to first response was 2.8 months and only one dose-limiting toxicity (side effect that justified a lower dose of the drug) was observed.
BGB-16673 is an oral medication (taken by mouth). It is a BTK inhibitor, a drug that works by binding to the BTK protein found on some types of cancer cells. In this way, the drug blocks a certain type of cell signaling that is necessary for cancer cells to grow and survive, according to a study published by the National Institutes of Health.
READ MORE: BTK inhibitors offer a revolutionary treatment for relapsed CLL/SLL
Researchers are currently enrolling patients in a Phase 2 cohort of the trial. According to the trial listing on ClinicalTrials.gov, the trial’s expected completion date is March 2028.
“BGB-16673 is the most advanced BTK degrader in the clinic and is well positioned to become an important therapy for patients whose disease progresses after BTKi and who have limited treatment options,” said Mobasher.
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