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

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

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 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 | "Clinical Trial Registration Number: ChiCTR2200065238 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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 | "Clinical Trial Registration Number: NCT06081673 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • 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) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

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 | "Clinical Trial Registration Number: NCT05726175 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 | "Clinical Trial Registration Number: NCT05028504 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

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 | "Clinical Trial Registration Number: NCT05563480 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • HAVCR2

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 | "Clinical Trial Registration Number: ChiCTR2300071925 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304) (AACR 2025) - P3 | "Penpulimab combined with gemcitabine and cisplatin or carboplatin demonstrated statistically significant and clinically meaningful benefit with a manageable safety profile, and provides a new beneficial treatment option in the first-line treatment for R/M NPC patients globally."

Clinical • Combination therapy • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

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

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma (FDA) - "On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy...Efficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398)....Efficacy of single-agent penpulimab-kcqx was evaluated in Study AK105-202 (NCT03866967)..."

FDA approval • Nasopharyngeal Carcinoma

Clinical Studies for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

The cost effectiveness of penpulimab with paclitaxel and carboplatin in first-line treatment of metastatic squamous non-small cell lung cancer. (PubMed, Sci Rep) - "Sensitivity analyses revealed that the cost of Penpulimab, along with the utilities of progression-free survival (PFS) and progression of disease (PD), were the parameters that most significantly influenced the model's outcomes. From the perspective of Chinese payers, Penpulimab offers a cost-effectiveness advantage over placebo in treating metastatic squamous NSCLC."

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

Critical Care Cardiology Escape Room Challenge - Aniket Rali (ACC 2025) - No abstract available

Cardiovascular • Critical care

Critical Care Cardiology Escape Room Challenge - Aniket Rali (ACC 2025) - No abstract available

Cardiovascular • Critical care

Cost-effectiveness analysis of penpulimab combined with paclitaxel and carboplatin as first-line treatment for advanced squamous non-small cell lung cancer. (PubMed, Front Pharmacol) - "These findings support its prioritization in clinical practice within the current WTP thresholds. However, the economic conclusions remain contingent on resolving the uncertainties associated with immature OS data and validating extrapolation assumptions through extended follow-up studies."

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

Sirolimus Efficacy in Treating Steroid-Resistant Immune-Mediated Liver Injury: Two Clinically Successful Case Reports (APASL 2025) - " Case 1 A 46-year-old male with pleomorphic sarcoma developed cholestasis-dominant ChILI after anti-PD-1 therapy (toripalimab and penpulimab). Initial treatment with methylprednisolone and mycophenolate mofetil failed, indicating steroid resistance...Magnesium isoglycyrrhizinate and ursodeoxycholic acid were ineffective, and artificial liver therapy was required... ICI-induced ChILI poses significant challenges in treatment, with limited benefits from traditional therapies and artificial liver support in refractory cases. Sirolimus showed significant efficacy in restoring liver function and alleviating symptoms in steroid-resistant patients. These findings suggest that sirolimus is a promising treatment for managing refractory irAEs."

Case report • Clinical • Cervical Cancer • Cholestasis • Hepatology • Liver Failure • Oncology • Sarcoma • Solid Tumor

Anlotinib + penpulimab plus chemo-less therapy in first-line treatment for persistent, recurrent, or metastatic cervical cancer: a single-arm, open-label phase Ⅱ study (ALTN-AK105-II-06) (SGO 2025) - No abstract available

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Akeso’s Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer (PRNewswire) - "Akeso Inc...announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy."

China approval • Nasopharyngeal Carcinoma

Cost-effectiveness analysis of penpulimab combined with paclitaxel and carboplatin as a first-line treatment for metastatic squamous non-small cell lung cancer in China. (PubMed, BMJ Open) - P3 | "Under the Chinese health system, penpulimab plus paclitaxel and carboplatin is cost-effective for metastatic sq-NSCLC patients and can be used as an economical and effective treatment option."

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

LARC-nCR01: Neoadjuvant Therapy for Locally Advanced Rectal Cancer (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P1 trial • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Cost-Effectiveness Analysis of Penpulimab Combined with Paclitaxel and Carboplatin as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer (Front Pharmacol) - "The incremental cost-effectiveness ratio (ICER) for the penpulimab group compared to the placebo group was $16,105.90 per quality-adjusted life year (QALY), which falls below the willingness-to-pay (WTP) threshold of $37,709.46 per QALY. Deterministic sensitivity analysis identified the three most influential factors affecting model outcomes: discount rate, costs associated with progressive disease, and utility value for progression-free survival. Probabilistic sensitivity analysis indicated that at a WTP threshold of $37,709.46 per QALY, the probability of penpulimab being cost-effective reached 99%."

HEOR • Lung Non-Small Cell Squamous Cancer

Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=99 | Completed | Sponsor: Akesobio Australia Pty Ltd | Active, not recruiting ➔ Completed | Phase classification: P1a/1b ➔ P1

Phase classification • Trial completion • Oncology • Solid Tumor