Hetronifly (serplulimab) / Abbott, Alvogen, Fosun Pharma, PT Kalbe Farma, Intas, Lotus Pharmaceutical, Eisai, Shanghai Henlius Biotech - LARVOL DELTA

Serplulimab Combined With Concurrent Chemoradiotherapy Followed by Serplulimabtherapy for LS-SCLC: A Phase 2 Trial (IASLC-WCLC 2026) - P2 | "Eligible patients received 4 cycles of serplulimab administered concurrently with etoposide plus cisplatin/carboplatin and thoracic radiotherapy, followed by serplulimab maintenance therapy until disease progression or for a maximum of 1 year. Conclusions : In this ongoing phase 2 trial, serplulimab combined with cCRT followed by serplulimab maintenance therapy has demonstrated promising antitumor activity and a favorable early survival trend, with acceptable tolerability and manageable safety profile. Longer follow-up is warranted to validate the survival benefits of this regimen."

P2 data • Lung Cancer • Pneumonia • Small Cell Lung Cancer • Solid Tumor

First-Line YL201 Plus Serplulimab in ES-SCLC and Advanced NSCLC: Phase 1 Results of a B7-H3-Directed Combination Strategy (IASLC-WCLC 2026) - P1 | "Conclusions : First-line YL201 plus serplulimab demonstrated a manageable safety profile and encouraging, durable anti-tumor activity across ES-SCLC and NSCLC cohorts. These findings support further evaluation of this B7-H3-directed combination strategy as a novel first-line strategy for lung cancers with substantial unmet need."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • CD276

First-Line Maintenance With Serplulimab for Extensive-Stage Small Cell Lung Cancer: A Post-Hoc Analysis and Meta-Analysis (IASLC-WCLC 2026) - "As shown in Table 1, compared with atezolizumab, serplulimab was associated with more favorable OS (hazard ratio [HR], 0.63; 95% CI, 0.48-0.81) and PFS (HR, 0.62; 95% CI, 0.49-0.80); compared with atezolizumab plus lurbinectedin, serplulimab was associated with improved OS (HR, 0.74; 95% CI, 0.57-0.97), similar PFS (HR, 1.01; 95% CI, 0.77-1.31), and an approximately 50% lower risk of grade ≥3 TRAEs (risk ratio, 0.52; 95% CI, 0.38-0.72). Conclusions : In this inter-study comparison, serplulimab was associated with more favorable OS and PFS than atezolizumab and with more favorable OS and safety than atezolizumab plus lurbinectedin."

Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Pathological Response and MRD Dynamics After Neoadjuvant Serplulimab Plus Chemotherapy in Stage IIB-IIIB(N2) LS-SCLC (IASLC-WCLC 2026) - P2 | "Patients received neoadjuvant therapy consisting of 4 cycles of serplulimab at 300 mg combined with etoposide and either cisplatin or carboplatin. MRD clearance after neoadjuvant therapy was associated with pCR, and surgery further facilitated MRD clearance. The early EFS data are promising; nevertheless, long-term follow-up is ongoing to further confirm the survival benefits of this strategy."

Clinical • Lung Cancer • Small Cell Lung Cancer • Solid Tumor

Latest efficacy and safety analysis of surufatinib combined with EP regimen and serplulimab as first-line treatment for extrapulmonary neuroendocrine carcinoma (ESMO 2026) - No abstract available

Clinical • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

Randomized trial of serplulimab or atezolizumab plus chemotherapy in USA patients with extensive-stage small cell lung cancer (ASTRIDE) (ESMO 2026) - No abstract available

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Immunotherapy for Digestive System Cancers: Progress, Challenges, and Future Directions. (PubMed, Biomedicines) - "Randomized phase III trials have established chemoimmunotherapy or dual-checkpoint strategies in advanced esophageal cancer, biomarker- and regimen-dependent first-line therapy in gastric cancer, PD-1-based therapy for MSI-H/dMMR colorectal cancer, atezolizumab-bevacizumab and STRIDE for unresectable hepatocellular carcinoma, and chemoimmunotherapy for advanced biliary tract cancer. Recent results also expand perioperative treatment: neoadjuvant checkpoint blockade produces high pathological response rates in dMMR colon cancer, adjuvant atezolizumab plus mFOLFOX6 improves disease-free survival in stage III dMMR colon cancer, and perioperative serplulimab improves event-free survival in PD-L1-positive resectable gastric cancer...Pembrolizumab-containing therapy did not meet superiority end points in KEYNOTE-062, the initial adjuvant signal in IMbrave050 was not sustained, and unselected pancreatic ductal adenocarcinoma remains largely resistant to checkpoint blockade...."

IO biomarker • Journal • Review • Biliary Cancer • Biliary Tract Cancer • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Hepatocellular Cancer • Microsatellite Instability • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MSI • PD-L1 • TIGIT

Complete pathological response after neoadjuvant chemoimmunotherapy in PD-L1-negative unresectable primary hepatic small cell carcinoma: a case report and tumor microenvironment analysis. (PubMed, Front Immunol) - "She received neoadjuvant therapy with cisplatin/carboplatin, etoposide, and serplulimab; after the first cycle, cisplatin was switched to carboplatin due to renal impairment. The response may be mediated by a chemotherapy-synergized, PD-1 inhibitor-driven immune activation within a receptive tumor microenvironment, particularly the stromal compartment. The presence of an immune-rich stroma may serve as a critical determinant for immunotherapy efficacy, highlighting the limitations of relying solely on tumor cell PD-L1 expression as a biomarker in this rare malignancy."

Biomarker • IO biomarker • Journal • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Renal Disease • Solid Tumor • CD38 • CD8 • PD-L1

A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=112 | Recruiting | Sponsor: People's Hospital of Quzhou | Phase classification: P1 ➔ P2

Phase classification • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Cost-effectiveness analysis of serplulimab plus chemotherapy for patients with extensive stage small cell lung cancer: Mexican private health system perspective (ESMO 2026) - No abstract available

Clinical • Cost effectiveness • HEOR • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Serplulimab combined with chemotherapy for extensive-stage small-cell lung cancer: a cost-effectiveness study in Brazil (ESMO 2026) - No abstract available

Cost effectiveness • HEOR • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CHOICE III: Short-Course Preoperative Radiotherapy Followed by Fruquintinib Plus Anti–PD-1 Antibody (Serplulimab) for Neoadjuvant Treatment of pMMR/MSS Mid-to-Low Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Prospective Phase II Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

A multicenter, prospective, randomized controlled trial of serplulimab plus bevacizumab with neoadjuvant chemoradiotherapy to improve complete response rate in locally advanced lower-middle rectal cancer (CHOICE IV). (ESMO 2026) - No abstract available

Clinical • Metastases • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Serplulimab Plus Anlotinib and S-1 in Second-Line or Later-Line Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Phase II Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

S-1 plus serplulimab consolidation after concurrent chemoradiotherapy in unresectable locally advanced esophageal squamous cell carcinoma: a phase II trial (ESMO 2026) - No abstract available

Metastases • P2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Health-related quality of life in the phase 3 trial ASTRUM-004 of first-line serplulimab plus chemotherapy for locally advanced or metastatic squamous non-small cell lung cancer (ESMO 2026) - No abstract available

Clinical • HEOR • Metastases • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Surufatinib Plus Serplulimab, Etoposide, and Carboplatin as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Updated Results from a Single-Arm, Phase Ia/Ib Trial (ESMO 2026) - No abstract available

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Flat-Dose Lurbinectedin Plus Serplulimab as First-Line Maintenance Therapy in Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: An Exploratory Study (ESMO 2026) - No abstract available

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

First-Line Fruquintinib Plus Serplulimab for Metastatic Non-Clear Cell Renal Cell Carcinoma: Updated Results From the Phase II FRONTIER Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Solid Tumor

Serplulimab plus Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm, Multicenter, Phase I/II Trial (SCR-ESCC-02) (ASTRO 2026) - P1/2 | "All pts received 2 cycles of induction Serplulimab (4.5 mg/kg, D1, Q3W) c, nab-paclitaxel (125 mg/m², D1,8, Q3W) and carboplatin (AUC=5, D1, Q3W). This combination therapy showed manageable toxicity that could provide a new strategy for locally advanced ESCC. Clinical trial information: NCT06173986"

Clinical • Metastases • P1/2 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant Short-Course Radiotherapy Combined with Immunochemotherapy vs. Chemotherapy Alone in pMMR Colon Cancers: The TORCH-C Randomized Phase 2 Clinical Trial (ASTRO 2026) - "Patients in the group B received 4 cycles of CAPOX (oxaliplatin 130 mg/m2 intravenously day 1 and capecitabine 1000 mg/m2 orally days 1-14). Patients in the group A received SCRT(25Gy in 5 fraction)and 4 cycles of the PD-1 inhibitor (serplulimab, 300mg intravenously day 1) combined with CAPOX... The combination of SCRT, PD-1 inhibitor, and chemotherapy shows promising efficacy and significantly improve pCR rates in patients with MSS/pMMR high-risk LACC. SCRT could be safely delivered by high-resolution CT image-guided ART."

Clinical • P2 data • pMMR • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Serplulimab Combined with CAPOX and Celecoxib as Neoadjuvant Therapy for Proficient Mismatch Repair Locally Advanced Mid-to-Low Rectal Cancer (SCAR) (ESMO 2026) - No abstract available

Clinical • Metastases • Mismatch repair • pMMR • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Neoadjuvant short-course radiotherapy followed by HLX07, serplulimab, and CAPOX in RAS/BRAF wild-type locally advanced rectal cancer (LARC): A multicenter, single-arm, phase II trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • BRAF

Health-related quality of life in the phase 3 ASTRUM-007 study of serplulimab or placebo plus chemotherapy for PD-L1-positive oesophageal squamous cell carcinoma (ESMO 2026) - No abstract available

Clinical • HEOR • P3 data • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Health-related quality of life in the phase 3 trial ASTRUM-002 of serplulimab plus chemotherapy with or without HLX04 for nonsquamous non-small cell lung cancer (ESMO 2026) - No abstract available

Clinical • HEOR • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor