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▲ 5 r/biotech

Telitacicept for IgA Nephropathy — Interim Analysis of a Phase 3 Trial

Remegene, Chinese asset licensed to Vor, score Phase 3 win in IgAN.

nejm.org
u/Dwarvling — 6 days ago
▲ 18 r/biotech

BeOne wins mantle cell lymphoma approval, opening new therapy class

iStock, AdrianHillman

Beqalzi is the first BCL2 inhibitor approved for relapsed or refractory mantle cell lymphoma.

The FDA has cleared BeOne Medicines’ BCL2 blocker sonrotoclax for the treatment of certain patients with mantle cell lymphoma, an approval that opens a new approach to treating this malignancy. The drug will carry the brand name Beqalzi.

Beqalzi is specifically indicated for patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have undergone at least two prior lines of systemic therapy, including a BTK inhibitor, according to a Thursday news release. Beqalzi was approved under the FDA’s accelerated pathway and will need a confirmatory study to verify its clinical benefits to sustain the approval.

Beqalzi is the first BCL2 inhibitor indicated for this indication, BeOne said. The drug is also the company’s third commercial product, coming after the BTK inhibitor Brukinsa, which was cleared in November 2019 for MCL, and the PD-1 inhibitor Tevimbra, which the FDA first approved in March 2024 for esophageal cancer.

Despite these distinctions, however, analysts at Truist Securities called Beqalzi’s approval “incremental,” pointing to the “relatively small” market for r/R MCL. The firm forecasts around $300 to $400 million in sales for Beqalzi in this indication.

Phase 1/2 data supported the FDA’s decision on Thursday. The trial, a single-arm open-label study, enrolled 125 patients with r/R MCL. Results demonstrated a 52% overall response rate, including a 16% complete response rate, BeOne said. Median duration of response was 15.8 months.

BeOne is currently running the Phase 3 CELESTIAL-RRMCL study, which will serve as Beqalzi’s confirmatory trial. The study has a primary completion date of August 2028.

Beqalzi is a next-generation BCL2 inhibitor that works by triggering cancer cell death. BeOne is studying Beqalzi as part of a fixed-duration regimen with Beqvez for chronic lymphocytic leukemia. Truist has higher hopes for this market than MCL, with peak sales of over $3.4 billion projected, according to the firm’s Thursday note.

While incremental on a market-level, Beqalzi’s approval is nevertheless good news for BeOne, which at the 2026 American Association for Cancer Research annual meeting in April presented underwhelming data. A Phase 2 readout at the conference showed that several combination regimens based on Tevimbra—including with the TIM-3 blocker surzebiclimab and the anti-LAG-3 therapy alcestobart—elicited no significant efficacy improvement over monotherapy in recurrent and/or metastatic head and neck squamous cell carcinoma.

u/Dwarvling — 7 days ago
▲ 8 r/biotech

BMS and Hengrui sign collaboration on 13 programs oncology, hematology and immunology for up to $15B

u/Dwarvling — 7 days ago
▲ 18 r/biotech

FDA Approves HER2/HER3 Bispecific for Advanced Bile Duct Cancer

Youssef Rddad

On May 8, the U.S. Food and Drug Administration (FDA) approved zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable or metastatic cholangiocarcinoma with a neuregulin 1 (NRG1) gene fusion whose disease progressed while on or after prior systemic therapy.

Regulators based their decision on results from the multicenter, open-label, multicohort, single-group eNRGy clinical trial, which assessed the bispecific antibody in patients with NRG1-positive solid tumors. The phase 1/2 study included 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma. Of these participants, 19 were evaluable for efficacy. 

Confirmed overall response rate (ORR) was the study’s primary endpoint, as assessed by a blinded independent central review using RECIST v1.1 criteria. Investigators also evaluated duration of response (DOR).

The ORR was 36.8% (95% confidence interval, 16.3%–61.6%), and the DOR ranged from 2.8–12.9 months.

The most common adverse reactions of zenocutuzumab-zbco include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.

The FDA noted that zenocutuzumab, a bispecific antibody targeting HER2 and HER3, includes warnings and precautions for infusion-related reactions, hypersensitivity and anaphylactic reactions, interstitial lung disease and pneumonitis, left ventricular dysfunction, and embryo-fetal toxicity in its prescribing information.

Zenocutuzumab’s recommended dosage is 750 mg as an intravenous infusion every two weeks. Treatment can continue until the occurrence of disease progression or unacceptable toxicity.In 2024, the FDA granted accelerated approval for zenocutuzumab for adults with advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma harboring a NRG1 gene fusion after disease progression while on or after prior systemic therapy.

The latest approval was part of the FDA Commissioner’s National Priority Review Voucher pilot program, which aims to accelerate product reviews that are considered national priorities. 

Patients with rare cancers are in desperate need of treatment options, said FDA Commissioner Marty Makary, MD, MPH, in a statement.

“Through the national priority voucher pilot program, the FDA is accelerating therapies for rare diseases with unmet medical needs, reviewing applications in significantly shortened timelines,” Dr. Makary said.

reddit.com
u/Dwarvling — 10 days ago