Editor’s Note: Since the PACIFIC study established sequential immunotherapy following chemoradiotherapy as the standard of care for unresectable stage III non-small cell lung cancer (NSCLC), the global focus has shifted toward further improving outcomes. At the 2025 ASCO Annual Meeting, the R-ALPS study (Abstract LBA8004), led by Professor Ming Chen and his team from the Sun Yat-sen University Cancer Center, was selected as a Late-Breaking Abstract (LBA), drawing widespread attention and sparking discussions across the oncology community This Phase III clinical trial is the first to explore a “dual maintenance” strategy using the domestic PD-L1 inhibitor bemosotamab in combination with the anti-angiogenic agent anlotinib. The results showed a median progression-free survival (PFS) of 15.1 months—superior to the monotherapy arm (9.7 months) and the placebo arm (4.2 months). Oncology Frontier invited Professor Chen to provide an in-depth analysis of the key findings and clinical implications of this milestone study.
01 | Oncology Frontier: First of all, congratulations on the release of this Late-Breaking Abstract. The R-ALPS study explores the value of dual maintenance therapy with TQB2450 and anlotinib in patients with unresectable, locally advanced NSCLC. What key challenges in current treatment practice does this study aim to address?
Professor Ming Chen | Sun Yat-sen University Cancer Center: In non-small cell lung cancer (NSCLC), about one-third of patients are diagnosed at a stage where complete surgical resection is not possible, yet distant metastases have not occurred. This is what we refer to as unresectable locally advanced NSCLC. The current standard of care involves maintenance therapy with a PD-L1 inhibitor following completion of chemoradiotherapy.
Based on this standard approach, our study was designed to explore two critical questions. First, can bemosotamab—a domestically developed PD-L1 inhibitor—demonstrate efficacy comparable to similar agents already approved internationally and within China? Second, can combining it with the anti-angiogenic agent anlotinib on top of standard immune maintenance therapy create a new, more effective “dual maintenance” regimen?
We enrolled 553 patients with unresectable stage III NSCLC in this study. The results met the primary endpoint: PFS assessed by the Independent Radiologic Review Committee (IRC). Bemosotamab monotherapy significantly outperformed placebo, and the combination of bemosotamab and anlotinib not only demonstrated superiority over placebo but also over bemosotamab monotherapy. Therefore, both key objectives of the study have essentially been achieved.
02 | Oncology Frontier: What survival outcomes were observed for the primary efficacy endpoint in the TQB2450 monotherapy group compared to the TQB2450 plus anlotinib combination group?
Professor Ming Chen | Sun Yat-sen University Cancer Center: Specifically, the median progression-free survival (PFS) for the bemosotamab monotherapy maintenance group reached 9.7 months, which was significantly longer than the 4.2 months observed in the placebo group. The dual maintenance regimen combining bemosotamab with anlotinib demonstrated even greater efficacy, with the median PFS further extended to 15.1 months. These results clearly indicate that the dual maintenance approach offers the most favorable survival benefit, followed by monotherapy—both showing significant advantages over placebo.
03 | Oncology Frontier: What is the theoretical rationale for combining TQB2450 with anlotinib as maintenance therapy? How does this combination synergistically improve the immune microenvironment after chemoradiotherapy?
Professor Ming Chen | Sun Yat-sen University Cancer Center: Anti-angiogenic therapy works by inhibiting tumor angiogenesis, thereby suppressing tumor growth and metastasis. This process induces a temporary window of vascular normalization, during which drug perfusion is enhanced. In this window, T-cell infiltration is improved, which strengthens the efficacy of immunotherapy and modulates the tumor immune microenvironment. This laboratory-based discovery forms the theoretical foundation for combining anlotinib with a PD-L1 inhibitor as a dual maintenance strategy, showing superior outcomes compared to monotherapy. That said, it’s important to acknowledge that the incidence of adverse events with dual maintenance is higher than with monotherapy.
04 | Oncology Frontier: Based on the R-ALPS study findings, do you believe the TQB2450 plus anlotinib regimen could become a new standard of care? Compared with the current standard, what are the main advantages of this combination?
Professor Ming Chen | Sun Yat-sen University Cancer Center: When compared with other data under the PACIFIC treatment model, the dual maintenance regimen in our study showed a slight advantage in efficacy, while maintaining a comparable safety profile. Based on these results, we remain optimistic about the potential approval of this regimen as a new treatment option, offering patients an additional and promising therapeutic choice.
▌Reference: Ming Chen, Yongling Ji, Long Chen, et al. R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy. ASCO 2025; Abstract LBA8004.
Sun Yat-sen University Cancer Center
- Director, Department of Radiation Oncology, Sun Yat-sen University Cancer Center
- Chief Lung Cancer Specialist, Sun Yat-sen University Cancer Center
- Director, Experimental Laboratory for Precision Radiotherapy, Sun Yat-sen University
- Standing Committee Member, Expert Committee on Radiation Therapy, Chinese Society of Clinical Oncology (CSCO)
- Standing Committee Member, Expert Committee on Radiation Therapy, Chinese Anti-Cancer Association
- Vice Chair, Radiation Oncology Branch, Chinese Medical Association
