The U.S. FDA has approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a known 17p deletion. This approval is based on the Phase 3 BRUIN CLL-313 trial, which showed that pirtobrutinib significantly improved progression-free survival (PFS) compared with a traditional chemotherapy combination, offering a new targeted therapy option for treatment-naive patients.

Key Data from the Phase 3 BRUIN CLL-313 Trial

The BRUIN CLL-313 trial randomly assigned 282 patients in a 1:1 ratio to receive pirtobrutinib 200 mg once daily or bendamustine plus rituximab (Rituxan) for up to 6 cycles. At a median follow-up of approximately 28 months, median PFS had not been reached in the pirtobrutinib group (NE; 95% CI, NE-NE), compared with 33.5 months in the control group (95% CI, 32.7-NE), with a hazard ratio (HR) of 0.20 (95% CI, 0.11-0.37; P < .0001). The overall response rate (ORR) was 94% (95% CI, 89%-98%) versus 81% (95% CI, 73%-87%); the complete response rate (CR) was 13% versus 21%.

Survival Trends and Safety Profile

At a median overall survival (OS) follow-up of 32.2 months, OS data favored pirtobrutinib (HR, 0.257; 95% CI, 0.070-0.934; P = .0261), with 24-month OS rates of 97.8% (95% CI, 93.3%-99.3%) versus 93.0% (95% CI, 87.0%-96.3%). The most common any-grade non-laboratory adverse reactions (occurring in at least 20%) included upper respiratory tract infection (27%), rash (22%), and COVID-19 (21%). The most common grade 3 or 4 laboratory abnormality was neutropenia, and 28% of patients experienced serious adverse reactions. The prescribing information carries warnings for infection, bleeding, cytopenias, arrhythmias, second primary malignancies, hepatotoxicity, and embryo-fetal toxicity.

Elinzanetant Receives Priority Review: Hot Flashes from Breast Cancer Hormone Therapy

The FDA has also granted priority review to a supplemental New Drug Application (sNDA) for elinzanetant (Lynkuet) for patients receiving hormone therapy to manage or prevent hormone receptor-positive breast cancer who have moderate to severe vasomotor symptoms (hot flashes). In the Phase 3 OASIS-4 trial, the elinzanetant 120 mg group (n = 316) reduced the mean daily frequency of moderate to severe vasomotor symptoms by 6.51 at week 4, compared with a reduction of 3.04 in the placebo group (n = 158) (LS mean difference, −3.5; 95% CI, −4.4 to −2.6; P < .0001); at week 12, reductions were 7.76 versus 4.20 (LS mean difference, −3.4; 95% CI, −4.2 to −2.5; P < .0001). Common adverse reactions included somnolence, headache, and fatigue.

What Does This Mean for Patients in Hong Kong?

For patients with CLL/SLL in Hong Kong, this FDA approval means there is an additional targeted therapy option in the first-line setting, and patients can discuss with their treating physician whether pirtobrutinib may be suitable instead of a traditional chemotherapy combination. Breast cancer patients who experience severe hot flashes due to hormone therapy can keep an eye on the review progress of elinzanetant and report their symptoms to their doctor so that treatment strategies can be adjusted. The study recruitment page on this site allows filtering of clinical trials in Hong Kong by cancer type, stage, and genetic mutation, helping you find suitable research opportunities.