Beigene Ltd Stock Price, News & Analysis

BeiGene, Ltd (NASDAQ: BGNE) announced the acceptance of a supplemental Biologics License Application (sBLA) by China's CDE for tislelizumab, an anti-PD-1 antibody aimed at treating patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors. This filing, based on positive Phase 2 trial results with 80 participants, marks the seventh indication for tislelizumab. The company aims to expand access to this potentially differentiated checkpoint inhibitor, reinforcing its commitment to addressing unmet medical needs.

BeiGene announced positive clinical results for its anti-PD-1 antibody, tislelizumab, at ASCO 2021. The Phase 3 RATIONALE 302 trial demonstrated a median overall survival (OS) of 8.6 months for tislelizumab versus 6.3 months for chemotherapy in advanced or metastatic esophageal squamous carcinoma (ESCC). Additionally, a Phase 2 trial reported an objective response rate (ORR) of 45.9% across various solid tumors. Both trials highlighted tislelizumab’s favorable safety profile. The company aims for broader international use of tislelizumab, advancing discussions with health authorities.

BeiGene announced positive results from clinical trials involving its PARP inhibitor, pamiparib, aimed at treating HER2-negative breast cancer and gastric cancer. The Phase 2 trial for HER2-negative breast cancer showed a confirmed objective response rate of 61.9% for HR(+) patients and 38.2% for TNBC patients. Although pamiparib showed a numerically higher progression-free survival in gastric cancer, it did not achieve statistical significance due to lower than expected enrollment. The company remains optimistic about pamiparib's potential in improving patient outcomes.

BeiGene announced positive interim results from the Phase 3 ALPINE trial, which compares BRUKINSA to ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial included 415 patients, with BRUKINSA showing non-inferiority in objective response rate (ORR) and statistically significant lower risk of atrial fibrillation compared to ibrutinib. The results will be presented at EHA2021, with further details discussed in an investor call.

BeiGene announced that its Phase 3 RATIONALE 309 trial evaluating tislelizumab, an anti-PD-1 antibody, in combination with chemotherapy for recurrent or metastatic nasopharyngeal cancer (NPC) successfully met its primary endpoint of progression-free survival (PFS). The interim analysis indicated a statistically significant improvement in PFS compared to chemotherapy alone. The trial included 263 patients, and the safety profile of tislelizumab remained consistent. This marks the fifth positive Phase 3 readout for tislelizumab, emphasizing its potential as a differentiated treatment option.

BeiGene, Ltd. (NASDAQ: BGNE) announced the presentation of clinical results at the 2021 ASCO Annual Meeting from June 4-8, showcasing advancements in its cancer treatment portfolio. Key highlights include initial reports from Phase 3 and Phase 2 trials of tislelizumab in various cancers and ongoing evaluations of next-generation BTK inhibitor, BRUKINSA. The company emphasizes its commitment to health equity and innovative treatments aimed at improving patient access and affordability. Presentations will be available starting June 4 at 9:00 a.m. ET via ASCO Digital Program.

BeiGene announced that the FDA has accepted a supplemental new drug application for BRUKINSA (zanubrutinib) aimed at treating adult patients with marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20 therapy. The FDA has prioritized the review, with a target action date set for September 19, 2021. This marks a significant step as MZL lacks a clear standard of care, affecting over 2,000 patients annually in the U.S. Clinical trials demonstrated promising efficacy and safety for BRUKINSA.

BeiGene, Ltd. (NASDAQ: BGNE) announced that key clinical results from its hematology program will be showcased at the EHA2021 Virtual Congress from June 9-17, 2021. The data includes promising results from the ALPINE and ASPEN trials, highlighting BRUKINSA's efficacy and tolerability across multiple B-cell malignancies. Additionally, long-term efficacy data for tislelizumab in classical Hodgkin’s lymphoma will be presented. New preliminary data for the BCL-2 inhibitor BGB-11417 is also anticipated. These updates aim to enhance patient outcomes and address unmet medical needs.

BeiGene, Ltd. (NASDAQ: BGNE) has received conditional approval from China's NMPA for pamiparib, a PARP inhibitor for gBRCA mutation-associated recurrent ovarian cancer post-chemotherapy. This marks BeiGene's third internally developed medicine to gain marketing authorization. The approval follows a pivotal Phase 2 trial showing an objective response rate of 68.3% for platinum-sensitive cases and 31.6% for platinum-resistant cases. Pamiparib is set to launch this month, and further trials are ongoing for additional indications.