Anniko (penpulimab) / Akesobio, Sino Biopharm, Specialised Therap - LARVOL DELTA

Penpulimab in an adolescent patient with pancreatic neuroendocrine carcinoma with liver metastasis: A case report and literature review. (PubMed, Medicine (Baltimore)) - "Pancreatic neuroendocrine cancer is rare. There are various treatment options available. However, the best treatment plan still needs further exploration. This case underscores that programmed death-1 ligand + PNEC may respond to immunotherapy/antiangiogenic combinations, offering alternatives for chemotherapy-ineligible patients. In addition, young patients with aggressive PNEC represent an understudied population, necessitating tailored strategies."

Journal • Review • Anorexia • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Efficiency and safety of neoadjuvant PD-1 inhibitor (penpulimab) combined with chemotherapy in resectable N1/N2 non-small cell lung cancer: a prospective cohort study. (PubMed, Int J Surg) - "This is the first report of neoadjuvant penpulimab in N1/N2 NSCLC, demonstrating efficacy, feasibility, and survival benefits, especially in patients with high tumor mutational burden."

IO biomarker • Journal • Tumor mutational burden • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • TMB

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Head and Neck Cancers, Version 3.2025. (NCCN)

NCCN guideline • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

Severe immunotherapy-related thrombocytopenia in metastatic bone cancer: a multicenter retrospective case series highlighting early recognition and management. (PubMed, Front Oncol) - "We retrospectively reviewed the clinical records of patients with metastatic bone cancer who received single-agent ICI therapy-specifically, PD-1 inhibitors such as pembrolizumab, penpulimab, and sintilimab-between May 2020 and December 2024 at three tertiary hospitals...All seven patients were undergoing combination therapy with the bone anti-resorptive agent denosumab...Timely diagnosis and comprehensive treatment-supported by interdisciplinary collaboration among oncologists, hematologists, and nursing staff-are essential for achieving full recovery. Furthermore, our findings emphasize the need for future research into predictive biomarkers and risk factors for irTP."

IO biomarker • Journal • Retrospective data • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Hematological Disorders • Melanoma • Oncology • Osteosarcoma • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thrombocytopenia • Undifferentiated Pleomorphic Sarcoma

An exploratory clinical study investigating the neoadjuvant treatment of HER2-low expressing, stage II-III breast cancer with disitamab vedotin combined with penpulimab (RCVDBCIIR005). (ASCO 2025) - P2 | "While the clinical benefit may be somewhat limited, the combination of Disitamab Vedotin and Penpulimab as neoadjuvant treatment for HER2-low early or locally advanced breast cancer demonstrates manageable safety and potential for furtheroptimization. This warrants additional investigation to refine and optimize treatment strategies."

Clinical • Breast Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Herpes Zoster • Oncology • Pruritus • Solid Tumor • Varicella Zoster • HER-2 • PD-L1

Neoadjuvant immunotherapy in combination with chemotherapy in resectable locally advanced head and neck squamous cell carcinoma: A randomized, open label, phase II clinical trial. (ASCO 2025) - P2 | "Patients will be randomized into three cohorts: Cohort 1 will receive ivonescimab (PD-1/VEGF antibody, 10 mg/kg), Cohort 2 will receive cadonilimab (PD-1/CTLA-4antibody, 6 mg/kg), and Cohort 3 will receive penpulimab (PD-1 antibody, 200 mg), all in combination with cisplatin and nab-paclitaxel... Neoadjuvant single- or dual-target immunotherapy combined with chemotherapy showed promising pathological responses in resectable LAHNSCC. While dual-target therapy showed potential benefits, the small sample size limits definitive conclusions. The treatment was well-tolerated, with no serious TRAEs."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Chemotherapy plus anti-PD-1 or anti-PD-L1 in advanced PD-L1–negative squamous cell lung carcinoma: A systematic review and meta-analysis. (ASCO 2025) - " A total of 1,548 patients with advanced PD-L1–negative sqNSCLC from 11 studies were included: IMpower131, RATIONALE 307, ORIENT-12, CameL-Sq, GEMSTONE-302, CheckMate 227 Part 1, KEYNOTE-407, Empower-Lung 3, ASTRUM-004, AK105-302, and POSEIDON... Our findings support the use of combination anti-PD-(L)1 plus chemotherapy as first-line therapy for patients with advanced PD-L1–negative sqNSCLC. Prospective studies are warranted to determine whether dual checkpoint inhibition, with or without chemotherapy, is superior to anti-PD-(L)1 plus chemotherapy in this population."

Metastases • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anlotinib in combination with penpulimab and chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A single-arm, prospective clinical study. (ASCO 2025) - P2 | "This regimen comprised Anlotinib Hydrochloride (10mg,QD, from day 1 to 14 of each 21-day cycle), Penpulimab (200md, on day 1 of each 21-day cycle), Etoposide (100 mg/m² on days 1-3 of each 21-day cycle), and either CBP (AUC=4-5 on day 1 every 3 weeks) or DDP (70-75 mg/m² on day 1 every 3 weeks). The combination of Anlotinib with Penpulimab and EP/EC regimens, has demonstrated superior PFS, OS, ORR, and DCR in initial ES-SCLC treatments, with manageable adverse events. A randomized, controlled phase III clinical study will be conducted to further validate these promising results."

Clinical • Combination therapy • Anemia • Fatigue • Hypertension • Lung Cancer • Nephrology • Neutropenia • Oncology • Otorhinolaryngology • Renal Disease • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia

A phase II clinical study of neoadjuvant penpulimab combined with chemotherapy for patients with locoregionally advanced, resectable squamous cell carcinoma of the head and neck. (ASCO 2025) - P2 | "Patients received three cycles of NICT consisting of penpulimab (200 mg), nab-paclitaxel (260 mg/m²), and cisplatin (75 mg/m²) on day 1 of each 21-day cycle, followed by surgery. Neoadjuvant penpulimab combined with chemotherapy demonstrated high ORR and MPR rates, with an acceptable safety profile in resectable HNSCC. These results support further investigation of this regimen in larger, randomized trials. Clinical trial information: NCT06081673."

Clinical • Metastases • P2 data • Head and Neck Cancer • Leukopenia • Oncology • Oral Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Preliminary results of anlotinib and penpulimab (anti-PD1) combined with GEMOX in first-line treatment of advanced biliary tract cancer: A single-center, single-arm exploratory study. (ASCO 2025) - "Participants received with anlotinib (10 mg, p.o., qd, d1-14, q3w), penpulimab (200 mg, iv, d1, q3W), gemcitabine (850mg/m2,iv,d1/8,q3w), and Oxaliplatin (85mg/m2,iv,d1,q3w). Anlotinib and Penpulimab combined with GEMOX as first-line therapy demonstrated promising efficacy and a manageable safety profile in patients with advanced BTC, though further data are needed to confirm these preliminary findings."

Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Hypertension • Leukopenia • Neutropenia • Oncology • Solid Tumor • KIT

A phase II study of anlotinib plus penpulimab as first-line treatment for persistent, recurrent, or metastatic cervical cancer: Results from ALTER-GO-020 trial. (ASCO 2025) - P2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT05028504 Background: In patients with recurrent, or metastatic cervical cancer, atezolizumab combined with bevacizumab and chemotherapy has significantly enhanced progression-free survival (PFS) and overall survival (OS) regardless of PD-L1 status. Anlotinib combined with penpulimab as a chemotherapy-free regimen showed a significant improvement in ORR, a trend towards longer PFS, and favorable safety in the treatment of pts with recurrent or metastatic cervical cancer. Clinical trial identification: NCT05028504."

Clinical • Metastases • P2 data • Cervical Cancer • Dermatology • Fatigue • Hypertension • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1

REMATCH2201: A phase II study on reducing surgical margins in HPV-negative advanced HNSCC with neoadjuvant PD-1 inhibitor and AP chemotherapy. (ASCO 2025) - P=N/A | "Participants received three cycles of the AP chemotherapy regimen combined with 200 mg of the PD-1 inhibitor Penpulimab... The REMATCH2201 trial supports the feasibility of reduced-margin surgery in patients with HPV-negative advanced HNSCC following effective neoadjuvant immunochemotherapy, without increasing the risk of oncologic recurrence. This approach importantly spares critical functional anatomy, advocating for a paradigm shift in the surgical management of these tumors. Nevertheless, further research in a multi-center, randomized controlled trial setting is required to substantiate these findings and refine protocols for broader application in clinical practice."

Clinical • Metastases • P2 data • Head and Neck Cancer • Squamous Cell Carcinoma of Head and Neck

Combination of Tim-3 blockade TQB2618 with penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): A multicenter, single-arm, two-cohort, phase 2 study. (ASCO 2025) - P2 | "TQB2618 and penpulimab were administered intravenously at doses of 1200 mg and 200 mg, respectively, on the first day of a 21-day cycle until disease progression or unacceptable toxicity while gemcitabine (1000 mg/m2, d1&8) and cisplatin (75mg/m2, d1) were given intravenously for the first 4–6 cycles. To our knowledge, this is the first study to evaluate the addition of Tim-3 blockade to the standard first-line treatment of R/M NPC. The results demonstrated that this combination therapy provided clinical benefits comparable to those observed in the historical cohort treated with PD-1 blockade plus chemotherapy, while maintaining a manageable safety profile."

Clinical • IO biomarker • Metastases • P2 data • Anemia • Hematological Disorders • Leukopenia • Nasopharyngeal Carcinoma • Neutropenia • Oncology • Solid Tumor • HAVCR2 • PD-L1

Neoadjuvant penpulimab combined with taxanes and carboplatin in triple-negative breast cancer: A single-arm, open-label, multi-center phase II clinical study (neoTAPPL). (ASCO 2025) - P=N/A | "Patients received 6 cycles of neoadjuvant therapy with penpulimab (200 mg, d1, q3w) plus taxanes (docetaxel 75 mg/m2 or nab-paclitaxel 260 mg/m2, d1, q3w) and carboplatin (AUC=6, d1, q3w). In this trial, we demonstrated that an anthracycline-free neoadjuvant regimen consisting of penpulimab, carboplatin and taxanes in TNBC showed promising antitumor efficacy and manageable safety profile. The study is still ongoing. Clinical trial information: ChiCTR2300071925."

Clinical • IO biomarker • P2 data • Anemia • Breast Cancer • Endocrine Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer

AK129 Combination Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=230 | Recruiting | Sponsor: Akeso | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A revision of the parasitoid wasp genus Dolichogenidea Viereck (Hymenoptera, Braconidae) in the Neotropical region, with the description of 102 new species. (PubMed, Zookeys) - "nov., one species formerly in the genus Apanteles: Dolichogenideacroceicornis (Muesebeck, 1958) and all 15 species formerly placed within Exoryza (six of them from the Neotropics): Dolichogenideaasotae (Watanabe, 1932), Dolichogenideabelippicola (Liu & You, 1988), Dolichogenideahylas (Wilkinson, 1932), Dolichogenideamariabustosae (Fernandez-Triana, 2016), Dolichogenideamegagaster (de Saeger, 1944), Dolichogenideaminnesota (Mason, 1981), Dolichogenideamonocavus (Valerio & Whitfield, 2004), Dolichogenideaoryzae Walker, 1994, Dolichogenideareticarina (Song & Chen, 2003), Dolichogenidearichardashleyi (Fernandez-Triana, 2016), Dolichogenidearitaashleyae (Fernandez-Triana, 2016), Dolichogenidearosamatarritae (Fernandez-Triana, 2016), Dolichogenideasafranum (Rousse & Gupta, 2013), Dolichogenideaschoenobii (Wilkinson, 1932) and Dolichogenideayeimycedenoae (Fernandez-Triana, 2016); 3) Dolichogenideayeimycedenoae (Fernandez-Triana, 2016) becomes a senior secondary..."

Journal

Penpulimab-kcqx-A Breakthrough in Nasopharyngeal Carcinoma Immunotherapy and the Urgent Need for Global Access. (PubMed, Asia Pac J Clin Oncol) - No abstract available

Journal • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

The prognostic value of ctDNA for postoperative patients with gastric cancer:interim analysisa from EXPLORING study (IGCC 2025) - "Interim data show that Patients with negative ctDNA have a better survival prognosis compared to those with positive ctDNA.This suggests that ctDNA is of significant importance in predicting the prognosis of gastric cancer patients after radical resection."

Circulating tumor DNA • Clinical • Gastric Cancer • Oncology • Solid Tumor

AK129 Combination Therapy for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=230 | Not yet recruiting | Sponsor: Akeso

New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Anlotinib plus penpulimab significantly improved progression-free survival and overall survival versus sorafenib in unresectable HCC and might be a new first-line option. These findings require verification in other regions of the world."

Journal • P3 data • Cardiovascular • Hepatocellular Cancer • Hepatology • Hypertension • Liver Failure • Oncology • Solid Tumor • AFP

Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial (Lancet Oncol) - P3 | N=648 | APOLLO (NCT04344158) | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | "Median follow-up was 6·2 months (IQR 5·5–7·5) for the anlotinib plus penpulimab group and 4·2 months (2·9–7·1) for the sorafenib group for final progression-free survival analysis, and 15·3 months (14·3–17·3) for the anlotinib plus penpulimab group and 14·5 months (11·5–17·0) for the sorafenib group for the second interim overall survival analysis. Median progression-free survival was significantly extended with anlotinib plus penpulimab versus sorafenib (6·9 months [95% CI 5·8–8·0] vs 2·8 months [2·7–4·1]; hazard ratio [HR] 0·52 [95% CI 0·41–0·66]; p<0·0001)."

P3 data • Hepatocellular Cancer

Drug type of adjuvant PD-1 inhibitors in hepatocellular carcinoma patients at high risk of recurrence after resection: a prospective, multicentric cohort study (APASL 2025) - P | "The corresponding median RFS for those receiving tislelizumab, sintilimab, camrelizumab, toripalimab, and penpulimab were 26.0 (95% CI 19.5–32.5, n=162), 30.4 (95%CI 22.4–38.4, n=101), 26.9 (95%CI 14.3–39.6, n=80), 32.5 (95%CI 21.6–43.5, n=22), and 31.0 (95%CI 12.8–49.2, n=13) months, respectively. Adjuvant PD-1 inhibitors improve the RFS and OS of patients with HCC at high risk of recurrence. There was no significant difference in the effectiveness of different types of PD-1 inhibitors."

Clinical • Hepatocellular Cancer • Oncology • Solid Tumor

Treatment of Retroperitoneal Well-Differentiated Liposarcoma with Combination of Penpulimab and Anlotinib: A Case Report and Literature Review. (PubMed, Niger J Clin Pract) - "After first-line treatment with Anlotinib combined with Penpulimab, the patient achieved almost complete remission with a progression free survival period of about 16 months. The first-line treatment of retroperitoneal well-differentiated soft tissue sarcoma using Anlotinib combined with Penpulimab resulted in a good prognosis."

Journal • Review • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

First-Line Penpulimab Plus Chemo Extends PFS in Recurrent or Metastatic Nasopharyngeal Carcinoma (OncLive) - P3 | N=296 | NCT04974398 | Sponsor: Akeso | "Penpulimab administered in combination with gemcitabine and platinum-based chemotherapy generated an improvement in progression-free survival (PFS) compared with placebo plus chemotherapy in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to data from the phase 3 Study AK105-304....Findings presented at the 2025 AACR Annual Meeting showed that at a median follow-up of 19.1 months (range, 0-31.5), patients treated in the penpulimab arm (n = 144) achieved a median PFS of 9.6 months (95% CI, 7.1-12.5) compared with 7.0 months (95% CI, 6.9-7.3) in patients treated in the placebo arm (HR, 0.45; 95% CI, 0,33-0.62; P < .0001). In the experimental arm, the 12- and 24-month PFS rates were 44.2% (95% CI, 34.9%-53.0%) and 22.8% (95% CI, 13.1%-34.0%), respectively. In the control arm, these respective rates were 15.4% (95% CI, 9.4%-22.7%) and 5.5% (95% CI, 1.6%-13.0%)."

P3 data • Nasopharyngeal Carcinoma

Economic Evaluation of Penpulimab Plus Paclitaxel and Carboplatin Combination Therapy as First-Line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer in China. (PubMed, Clin Drug Investig) - "Our analysis suggests that penpulimab plus paclitaxel and carboplatin combination therapy is cost-effective for patients with locally advanced or metastatic sqNSCLC in China."

HEOR • Journal • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor