Betta Pharmaceuticals Co., Ltd.

Pfizer (NYSE: PFE) reported seven-year follow-up data from the Phase III CROWN trial showing that 55% of previously untreated ALK-positive non-small cell lung cancer patients receiving lorlatinib (Lorbrena) remained alive without disease progression — a landmark in a disease where durable control at this timepoint has not previously been documented. The CROWN trial is a randomized, open-label, Phase III study that enrolled 296 patients with previously untreated ALK-positive advanced or metastatic NSCLC, randomized 1:1 to lorlatinib (n\=149) or Pfizer’s Xalkori (crizotinib) (n\=147). The seven-year analysis, an unplanned post-hoc assessment prompted by the fact that median progression-free survival remained unreached at both the three- and five-year marks, was based on investigator tumor assessment and presented at the 2026 ASCO Annual Meeting (Abstract #8502), with simultaneous publication in Annals of Oncology. At seven years, the probability of remaining alive without progression was 55% (95% CI: 46–63) with lorlatinib versus 3% (95% CI: 1–8) with crizotinib. Investigator-assessed median PFS was not reached in the lorlatinib arm, with a hazard ratio of 0.19 (95% CI: 0.13–0.26), representing an 81% reduction in the risk of progression or death. The intracranial data were similarly striking: lorlatinib reduced the risk of intracranial progression by 94% (HR 0.06; 95% CI: 0.03–0.12), with no new intracranial progression events observed after the first 30 months. At the time of analysis, 44% of patients in the lorlatinib arm remained on treatment, compared with 3% in the crizotinib arm. The safety profile was consistent with prior analyses. Grade 3/4 adverse events occurred in 77% of lorlatinib patients versus 57% with crizotinib, though treatment-related discontinuations were low and comparable — 5% versus 6%, respectively — with no new permanent discontinuations due to treatment-related adverse events after the first 26 months on lorlatinib. Lorlatinib is a third-generation ALK/ROS1 tyrosine kinase inhibitor engineered specifically to overcome resistance mutations that limit earlier-generation agents and to penetrate the blood-brain barrier — properties that appear central to the durability seen in CROWN. The first-line ALK-positive NSCLC space now includes several approved oral agents: Roche’s Alecensa (alectinib), Takeda’s Alunbrig (brigatinib), Novartis’s Zykadia (ceritinib), and, most recently, Xcovery’s Ensacove (ensartinib), approved in December 2024. Cross-trial comparisons are limited by differences in patient populations, follow-up duration, and analytical methods, but no other agent in this class has reported a median PFS that remains unreached at seven years. Overall survival data from CROWN remain immature, and those results will be the next material readout for the program. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

WATERTOWN, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- EyePoint, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that company management will participate at the following upcoming conferences: Stifel 2026 Virtual Ophthalmology ForumForum: Fireside ChatDate: May 26, 2026Time: 9:00 am ET Jefferies Global Healthcare ConferenceForum: Fireside Chat Date: June 3, 2026Time: 4:55 p.m. ETGoldman Sachs 47th Annual Global Healthcare Conference Forum: Fireside ChatDate: June 9, 2026Time: 11:20 a.m. ET A webcast and subsequent archived replay of each fireside chat may be accessed via the Investors section of the Company website at www.eyepoint.bio. About EyePoint EyePoint, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company’s lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data across multiple clinical trials and indications, DURAVYU is currently being evaluated in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Topline data is expected for wet AMD beginning in mid-2026. The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Investors: Tanner Kaufman / Jenni LuFTI Consulting tanner.kaufman@fticonsulting.com / jenni.lu@fticonsulting.com Media: Helen O’GormanFTI Consultinghelen.ogorman@fticonsulting.com

BeOne Medicines (formerly BeiGene; Basel, Switzerland; Nasdaq: ONC) appears to have terminated a Phase I clinical trial for BG-60366, an orally administered chimeric degradation activation compound (CDAC) designed to degrade mutant epidermal growth factor receptor (EGFR) protein. A Phase I clinical trial assessing the drug candidate in patients with EGFR-mutant non-small cell lung cancer (NSCLC) has been listed as terminated on the clinicaltrials.gov platform, with the decision described as reflecting an “evaluation on business strategy” rather than safety issues. The Phase I, open-label, multicenter, non-randomized trial had enrolled 33 participants before being halted ahead of its May 2026 primary completion date, with no efficacy, safety, or pharmacokinetic data released publicly. The trial enrolled adults with histologically or cytologically confirmed advanced or metastatic NSCLC carrying EGFR activating mutations who had progressed on prior third-generation EGFR tyrosine kinase inhibitor (TKI) therapy. The safety expansion cohort specifically required documentation of EGFR resistance mutations, including the C797S substitution — a mechanism of acquired resistance to osimertinib (Tagrisso) that eliminates covalent binding at the drug’s target cysteine residue. Prior treatment with fourth-generation EGFR-TKIs or other CDAC or PROTAC compounds targeting EGFR resistance mutations was an exclusion criterion. Sites spanned the US, China, Australia, South Korea, Spain, Italy, Brazil, Thailand, Malaysia, and New Zealand, with enrollment active at institutions including Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, and Peter MacCallum Cancer Centre. The CDAC modality itself presents specific early-phase challenges that may have been relevant. Oral bioavailability for compounds in this class is frequently suboptimal, and the efficiency of ternary complex formation between the degrader, target protein, and E3 ligase can be difficult to predict from preclinical models. A “hook effect” — reduced degradation activity at higher concentrations due to formation of unproductive binary complexes — is a known class liability. Whether any of these factors contributed to the decision to halt BG-60366 development cannot be established from the available public record. Pipeline context The BeiGene clinical trial termination of BG-60366 occurred during a period of deliberate portfolio rationalization at BeOne Medicines. The company, which rebranded from BeiGene and redomiciled to Basel, Switzerland in 2025, simultaneously shelved several other early-stage oncology programs including a pan-KRAS inhibitor, a MAT2A inhibitor, a CDK2 inhibitor, and an anti-CCR8 monoclonal antibody, as well as a Phase II rheumatoid arthritis study. BeOne’s current development priorities center on Brukinsa (zanubrutinib), its approved BTK inhibitor generating the bulk of company revenue, alongside sonrotoclax, BGB-16673 — a BTK-targeted CDAC in hematology — and zanidatamab in HER2-positive solid tumors. BG-60366, as an early-stage exploratory asset that had not yet established proof of concept, occupied a different tier of the portfolio. The company had previously indicated internal proof-of-concept data readouts for BG-60366 were expected in the second half of 2025, a timeline that subsequently shifted to the first half of 2026 before the trial was terminated. Acquired resistance to third-generation EGFR-TKIs, particularly osimertinib, represents one of the central unresolved problems in NSCLC management. The C797S resistance mutation, which abolishes covalent binding of osimertinib to EGFR exon 20, occurs in a subset of patients progressing on third-generation therapy and has no approved targeted treatment. Protein degradation as a strategy to overcome this resistance is mechanistically rational — by routing the entire EGFR protein to the proteasome rather than relying on covalent inhibition, degraders can in principle remain active against C797S-bearing EGFR. However, the clinical translation of EGFR-targeted degraders has proven difficult. Other companies that have suffered clinical setbacks include C4 Therapeutics’ CFT8919, partnered with Betta Pharmaceutical, which was pulled earlier this year according to the firm’s Q1’26 financial report. The competitive environment includes both fourth-generation EGFR-TKI programs designed to address resistance mutations through allosteric or non-covalent mechanisms and other CDAC or PROTAC approaches. Of note, AstraZeneca exercised an option to co-develop a bispecific antibody-based EGFR degrader from Pinetree Therapeutics in April this year. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Copyright © 2026. AllSci Corp. All rights reserved.