Atezolizumab

Sichuan Kelun-Biotech Biopharmaceutical (HKEX: 6990.HK) has reported that its Phase III OptiTROP-Lung06 trial of sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) plus Merck’s Keytruda (pembrolizumab) met its primary endpoint of progression-free survival in first-line PD-L1-negative non-squamous non-small cell lung cancer — a population where immunotherapy alone offers limited benefit and platinum-based chemotherapy remains the backbone of treatment. The result extends the clinical case for sac-TMT beyond PD-L1-positive disease. In the companion OptiTROP-Lung05 study, sac-TMT plus pembrolizumab previously demonstrated superiority over pembrolizumab monotherapy in PD-L1-positive NSCLC, with those findings presented at ASCO 2026 and published in The Lancet. Together, the two trials position sac-TMT as a potential first-line option across the full spectrum of PD-L1 expression in driver gene-negative non-squamous NSCLC. The findings also strengthen the clinical foundation for Merck’s global development program for sac-TMT, which the company licensed outside Greater China in 2022. Sac-TMT is a TROP2-directed antibody-drug conjugate that delivers a belotecan-derived topoisomerase I inhibitor payload intracellularly, inducing DNA damage and apoptosis in tumor cells while enabling bystander killing of adjacent cells through membrane-permeable payload release. The combination with pembrolizumab, which blocks the PD-1 checkpoint to restore T-cell-mediated tumor killing, is designed to exploit synergistic immune and cytotoxic mechanisms — potentially overcoming the limited immunotherapy response seen in PD-L1-low or -negative tumors. OptiTROP-Lung06 is a randomized, open-label, multicenter Phase III trial comparing sac-TMT plus pembrolizumab against pembrolizumab plus pemetrexed and platinum-based chemotherapy. At a pre-specified interim analysis, the combination demonstrated a statistically significant and clinically meaningful PFS improvement, with a positive OS trend also observed. The safety profile was consistent with prior studies, with no new signals identified. Specific numerical data — median PFS, hazard ratios, and p-values — were not disclosed in the announcement. Kelun-Biotech plans to engage China’s Center for Drug Evaluation based on these results. Sac-TMT already holds four approved indications in China, including previously treated EGFR-mutant non-squamous NSCLC and triple-negative breast cancer, and is the world’s first TROP2-directed ADC approved for lung cancer. A new indication application for first-line PD-L1-positive NSCLC based on the Lung05 study is under priority review at China’s NMPA. The Lung06 results could support an additional regulatory submission seeking to expand use into the PD-L1-negative first-line setting. Merck holds exclusive rights to develop and commercialize sac-TMT outside Greater China and has 17 ongoing global Phase III studies evaluating the molecule. The PD-L1-negative first-line setting is currently treated with pembrolizumab plus pemetrexed and platinum chemotherapy — the regimen against which Lung06 was evaluated — alongside atezolizumab-based regimens and dual checkpoint combinations such as nivolumab plus ipilimumab. These approaches rely on chemotherapy or dual immunotherapy to achieve meaningful benefit in this population. If confirmed in full data presentation, an ADC-plus-checkpoint regimen capable of replacing cytotoxic chemotherapy could represent a meaningful shift in first-line treatment, although cross-trial comparisons remain limited until detailed results are presented and peer-reviewed. 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 Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and rivoceranib at the FDA. U.S. regulators have declined to approve the anti-PD-1/VEGFR combo for a third time as a first-line treatment for liver cancer, Hengrui and Elevar’s parent company, HLB Group, said in separate announcements Friday. The problem, again, is manufacturing. Only this time, the complete response letter (CRL) stemmed from deficiencies the FDA had identified in April at the plant producing rivoceranib, also known as apatinib, unlike the previous two rejections , which centered on Hengrui’s camrelizumab facility, according to the Chinese pharma. The rivoceranib manufacturer had passed an inspection by EU authorities in 2025, it noted. Still, three CRLs do not necessarily mean three strikes and you're out for Hengrui and Elevar. “The company has thoroughly evaluated the regulator’s feedback and is taking steps to implement appropriate corrective measures,” Hengrui said in a securities filing (Chinese, PDF) in Shanghai. “The company will actively communicate with the FDA and our partner, Elevar Therapeutics, to establish the next resubmission plan.” Elevar “intends to promptly address the aforementioned deficiencies and resubmit the application for FDA approval,” HLB said in its own securities filing to the Korea Exchange. As Elevar noted, a re-inspection by the FDA may be required to determine that the facility meets CGMP compliance requirements. More than two years have passed since the FDA first snubbed the camrelizumab-rivoceranib regimen in May 2024. The second CRL arrived in March 2025. And Elevar refiled the newest application on Jan. 23, 2026. The latest CRL does not raise any issues with clinical data, Hengrui said. For this application, the two companies provided updated final analysis from the phase 3 Cares-310 trial, which showed a 36% death risk reduction for camrelizumab and rivoceranib versus Bayer’s Nexavar in first-line unresectable hepatocellular carcinoma. Chinese companies have long viewed follow-on PD-1 inhibitors as a viable entry point into the highly lucrative U.S. innovative drug market. However, these candidates have faced a string of regulatory and operational setbacks along the way. In a high-profile decision that triggered ripple effects across the industry, the FDA in 2022 refused to approve Innovent Biologics’ then Eli Lilly-partnered Tyvyt, citing predominantly China-only data as a problem. Thanks to that policy, Novartis abandoned its U.S. submission plan in first-line non-small cell lung cancer for Tevimbra before returning the asset to BeOne Medicines, then known as BeiGene. The same fate met CStone Pharmaceuticals’ PD-L1 inhibitor sugemalimab and its partnership with EQRx, which was absorbed into Revolution Medicines in 2023. Besides Hengrui, Fosun Pharma is also angling its China-approved PD-1 inhibitor, serplulimab, for an initial FDA approval in extensive-stage small cell lung cancer. Despite the positive phase 3 Astrum-005 trial, which showed the drug beat placebo, both added to chemotherapy, Fosun had to conduct a U.S. bridging study that compared serplulimab to Roche’s Tecentriq. With that study recently complete, Fosun is in discussions with the FDA about a potential filing this year.