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Lydia Scarfò, MD, explains the rationale for evaluating the BTK degrader BGB-16673 for patients with relapsed/refractory CLL.
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“The treatment of patients with chronic lymphocytic leukemia has radically changed in the last few years, thanks to the introduction of BCL-2 and BTK inhibitors. [However,] the issue is that patients exposed to BTK inhibitors and BCL-2 inhibitors still have the chance to relapse, and they become a difficult-to-treat population.”
Lydia Scarfò, MD, an assistant professor of internal medicine at the Università Vita-Salute San Raffaele and a consultant hematologist at the Strategic Research Program on CLL, explained the rationale for evaluating the BTK degrader BGB-16673 for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
Over the past few years, the treatment landscape of CLL has significantly changed, largely because of BCL-2 and BTK inhibitors, Scarfò began. Nevertheless, she noted that patients with CLL who are exposed to BTK and BCL2 inhibitors may still relapse, which can make this particular patient population more difficult to treat. Therefore, utilizing treatments with a different mechanism of action could help overcome resistance and help achieve long-term disease control, she explained.
BGB-16673 targets BTK, which is essential for the survival and proliferation of CLL cells. Unlike conventional BTK inhibitors, BGB-16673 targets BTK degradation through the proteasome pathway, Scarfò concluded.
The phase 1 CaDAnCe-101 trial (NCT05006716) evaluated the safety and efficacy of BGB-16673. Results from the study showed that, at the 200 mg dose level (n = 16), the overall response rate was 93.8%. This comprised 1 patient who achieved a complete response (CR) or CR without incomplete marrow recovery, and 12 patients who achieved partial responses.
The most common treatment-emergent adverse effects (TEAEs) were fatigue (37%), contusion (30%), diarrhea (29%), neutropenia (29%), anemia (23%), cough (18%), pyrexia (17%), pneumonia (16%), COVID-19 (15%), dyspnea (15%), increased lipase (15%), thrombocytopenia (14%), arthralgia (12%), peripheral edema (12%), increased amylase (11%), and nausea (11%). Of note, low-grade atrial fibrillation occurred in 2 patients, and major hemorrhage occurred in 2 patients, one being a grade 3 subdural hemorrhage.
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