Pharma RSS Digest - 2026-05-23
Overview
The Friday, May 23, 2026 digest is dominated by ASCO preview activity, with multiple oncology companies announcing data presentations set for the upcoming conference in Chicago. Kelun-Biotech stands out with Phase III evidence supporting sac-TMT combined with pembrolizumab in first-line PD-L1 positive NSCLC, marking the first ADC combination to demonstrate a progression-free survival benefit against pembrolizumab monotherapy in this setting. The regulatory pipeline is also active, with Nuvalent filing for neladalkib approval and both Kelun-Biotech candidates under NMPA review in China. Meanwhile, the layoff tracker confirms continued industry consolidation, with BMS, Astellas, Replimune, and BioNTech each announcing workforce reductions tied to strategic shifts or regulatory setbacks.
Key Developments
Kelun-Biotech presents dual NSCLC data sets at ASCO
Zimmer Biomet fda approval update
Kelun-Biotech will highlight two late-stage datasets at ASCO 2026, both now published in full abstracts. The Phase III OptiTROP-Lung05 trial (n=413) demonstrated that sac-TMT, the world's first TROP2 ADC approved for lung cancer, combined with pembrolizumab achieved a 70.2% objective response rate versus 42.0% for pembrolizumab alone as first-line treatment for PD-L1 positive advanced NSCLC, with progression-free survival hazard ratio of 0.35. The regulatory filing for this combination has been accepted for priority review by China's NMPA, and MSD is simultaneously running 17 global Phase III studies of the ADC outside Greater China. Separately, lunbotinib fumarate showed 87.1% ORR in pre-treated and 81.3% in treatment-naïve RET-fusion positive NSCLC patients in a Phase II pivotal study, with high intracranial response rates in brain metastasis patients; its NDA is also under NMPA review. The emerging competition in TROP2 ADC space against Gilead's Trodelvy is worth monitoring, particularly as global data from MSD's trials emerge.
Kelun-Biotech clinical trial update
Nuvalent advances ALK inhibitor toward FDA decision
Nuvalent announced that pivotal neladalkib data from the ALKOVE-1 trial will be presented at ASCO (Abstract 8503, May 29), supporting the FDA NDA submission made in April 2026 for TKI pre-treated advanced ALK-positive NSCLC patients. The company is also running the Phase 3 ALKAZAR trial comparing neladalkib to alectinib in TKI-naïve patients, which could expand the drug's positioning earlier in the treatment paradigm. A separate presentation on zidesamtinib (Abstract 3108) will showcase preliminary data from the ARROS-1 trial showing activity across 15 response-evaluable patients with ROS1-positive solid tumors beyond NSCLC. Nuvalent's ALK-selective, TRK-sparing kinase inhibitor design aims to address brain metastases and resistance mutations while improving tolerability over existing TKIs. The FDA's decision timeline and ALKAZAR outcomes are the next catalysts to track.
Rigel reports positive AcceleRET-Lung readout with safety signal to watch
Rigel announced that the Phase 3 AcceleRET-Lung trial of GAVRETO (pralsetinib) met its primary progression-free survival endpoint and showed significantly greater overall response rates versus standard of care in RET fusion-positive NSCLC, with final data scheduled for oral presentation at ASCO (Abstract 8504, May 29). However, safety data revealed 8 infection-related deaths (7.4%) in the pralsetinib group versus zero in the standard of care arm, which will require careful physician assessment despite the company's position that increased monitoring can manage severe infection risk. Separately, REZLIDHIA (olutasidenib) demonstrated robust real-world effectiveness in relapsed/refractory mIDH1 AML patients post-venetoclax, with a 60.8% complete remission/complete remission with partial hematological recovery rate and median response duration of 30.3 months. Additional olutasidenib data and long-term survival outcomes (74% at 48 months) will be presented at the EHA Congress in June. The infection safety signal for GAVRETO warrants close attention as prescribers weigh benefit-risk.
Layoff tracker confirms continued industry restructuring
Bristol Myers Squibb is cutting 206 additional employees at its Lawrenceville, New Jersey site (effective July through December 2026), adding to 247 layoffs at the same location in February and over 1,200 job reductions across five separate events in 2025. Astellas Pharma is closing Universal Cells' Seattle office, affecting 50 employees, and consolidating cell and gene therapy operations to South San Francisco and Westborough, Massachusetts. Replimune announced 63 job cuts in Woburn, Massachusetts following the second FDA rejection of melanoma drug RP1. BioNTech is shutting its Singapore mRNA manufacturing plant by February 2027, affecting 85 workers, less than four years after acquiring the facility from Novartis. The pattern of manufacturing scale-backs and geographic consolidation continues across the industry, with mRNA technology facing ongoing headwinds.
Watchlist
- React Health ventilator recall: The FDA classified the VOCSN V+Pro ventilator recall as most serious, with a manufacturing test error potentially causing undetected oxygen leaks that could reduce delivered oxygen or increase fire risk. Customers must stop use immediately. No serious injuries or deaths have been reported as of early March, but the device count affected remains unconfirmed. [link]
- Servier's vorasidenib three-year INDIGO follow-up: Updated Phase 3 data for VORANIGO in Grade 2 IDH-mutant glioma will be presented at ASCO, with sustained progression-free survival benefits and new quality-of-life analyses. A placebo-controlled trial in Grade 3 astrocytoma is also underway under Alliance leadership. [link]
- Innovent Biologics' IBI363 advances to Phase 3: The PD-1/IL-2α bispecific fusion protein demonstrated median OS of 18.2 months in squamous NSCLC (versus 9.4 months for docetaxel) and has entered a global Phase 3 trial (MarsLight-11) for IO-resistant squamous NSCLC. Takeda partnered on global co-development in October 2025. [link]
- Boehringer Ingelheim's HERNEXEOS expansion data: Zongertinib showed activity across HER2-driven tumors including 42% ORR in colorectal cancer, 62.5% in gastric cancer when combined with trastuzumab deruxtecan, and rapid symptom improvement in NSCLC. The DLL3/CD3 bispecific obrixtamig demonstrated 73% ORR in first-line extensive-stage small cell lung cancer. [link]
- Accent Therapeutics' ATX-295 first-in-human study: The oral KIF18A inhibitor targets chromosomal instability in aneuploid tumors and is enrolling patients with high-grade serous ovarian cancer and squamous NSCLC. A "Trial in Progress" poster will be presented at ASCO with no preliminary efficacy data yet released. [link]