pimurutamab (HLX07) / Fosun Pharma - LARVOL DELTA

APPLICATION FOR PHASE 1B/2 CLINICAL TRIAL OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) IN COMBINATION WITH HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION) FOR THE TREATMENT OF ADVANCED/METASTATIC SOLID TUMOURS WAS APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews)

New P1/2 trial • Solid Tumor

First-Line HLX07 Plus Serplulimab With or Without Chemotherapy in Squamous Non-Small Cell Lung Cancer: A Phase 2 Study (IASLC-WCLC 2025) - "Patients with stage IIIB/IIIC or IV sqNSCLC that was not amenable to surgery or radiation therapy and high tumor expression of epidermal growth factor receptor (H score≥150) and no prior systemic therapy were randomized 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy (carboplatin and nab-paclitaxel), once every three weeks. 6 (46.2%) patients, and 8 (57.1%) in group A, and B reported immune-related adverse events, respectively. Conclusions : First-line HLX07 plus serplulimab and chemotherapy showed promising preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation."

Clinical • IO biomarker • P2 data • Alopecia • Anemia • Endocrine Disorders • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC (Henlius Press Release) - "2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer(IASLC) will be held from September 6-9 in Barcelona, Spain‌. At the conference, Henlius will showcase 10 latest results from its innovative products on lung cancer, which includes 3 oral presentations and 2 poster tours, covering updated phase 1 clinical data‌ for PD-L1 ADC HLX43, the results(first release) from ASTRUM-002, a phase 3 clinical trial of serplulimab (anti-PD-1 monoclonal antibody) in the first line treatment of advanced non-squamous non small cell lung cancer (NSCLC) as oral presentation, along with further research findings on serplulimab in lung cancer, making it the Chinese biopharmaceautical with most oral presentations."

Clinical data • Lung Non-Squamous Non-Small Cell Cancer • Small Cell Lung Cancer

A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer. (ASCO 2025) - P2 | "Patients with stage IIIB/IIIC or IV sqNSCLC that was not amenable to surgery or radiation therapy and high tumor expression of epidermal growth factor receptor (H score≥150) and no prior systemic therapy were randomized 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy (carboplatin and nab-paclitaxel), once every three weeks. First-line HLX07 plus serplulimab and chemotherapy showed encouraging preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation."

Clinical • IO biomarker • Metastases • P2 data • Alopecia • Anemia • Endocrine Disorders • Immunology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Wuhan Union Hospital, China | Active, not recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • BRAF

Henlius to Showcase Latest Results of 5 Clinical Trails at ESMO Asia 2024 (Henlius Press Release) - "From 6 to 8 December 2024, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including HANSIZHUANG (serplulimab), HLX07 (anti-EGFR mAb), and daratumumab biosimilar HLX15."

Clinical data • Nasopharyngeal Carcinoma • Non Clear Cell Renal Cell Carcinoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma

First-line HLX07 vs. placebo combined with serplulimab and chemotherapy for nasopharyngeal cancer: A randomised, double-blind, multicentre phase II study (ESMO Asia 2024) - P2 | "Serplulimab (300 mg), and chemotherapy (gemcitabine and cisplatin) were also given Q3W for up to 2 years, and 6 cycles, respectively. Conclusions The addition of HLX07 to serplulimab and chemotherapy showed preliminary efficacy along with a manageable safety profile. This treatment regimen warrants further investigation as a potential first-line option for R/M-NPC patients."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Efficacy and safety of HLX07 monotherapy in advanced cutaneous squamous cell carcinoma: An open-label, multicentre phase II study (ESMO Asia 2024) - P2 | "No TRAE leading to treatment discontinuation or death was reported. Conclusions With an additional 8.9 months of follow-up, HLX07 monotherapy at 1000 mg continued to demonstrate encouraging antitumour efficacy along with manageable safety in Chinese patients with advanced CSCC."

Clinical • Metastases • Monotherapy • P2 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

HLX07 alone or combined with serplulimab, cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study. (PubMed, Cancer Commun (Lond)) - P2 | "HLX07 monotherapy and its combination with serplulimab and chemotherapy showed manageable toxicity and promising antitumor activity in patients with recurrent or metastatic ESCC. Randomized controlled trials are warranted to further establish the safety and efficacy of HLX07 against ESCC."

Journal • Metastases • P2 data • Endocrine Disorders • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Fatigue • Oncology • Pneumonia • Squamous Cell Carcinoma

Encorafenib/Cetuximab Plus FOLFIRI Shows Promise in mCRC (OncLive) - '"The combination of EC plus FOLFIRI was tolerable without new safety signals in patients with BRAF V600E-mutant mCRC…[and] showed promising improvement in key efficacy measures,' said Tabernero..."

Media quote

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: Wuhan Union Hospital, China

Metastases • New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor • BRAF

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Sep 2024

Enrollment closed • Metastases • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

First-line HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy in advanced/recurrent squamous non-small cell lung cancer: A phase II study (ESMO Asia 2023) - P2 | "Patients with stage IIIB/IIIC or IV sqNSCLC that could not be treated with surgery or radiation therapy and had not received prior systemic therapy were enrolled and randomised 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), combined with serplulimab (300 mg) and chemo (carboplatin and nab-paclitaxel), Q3W. No TEAE leading to death was reported. Conclusions First-line HLX07 plus serplulimab and chemo conferred encouraging antitumour efficacy with a manageable safety profile in patients with advanced sqNSCLC and warrants further investigation."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Results from Four Phase 1/2 Clinical Trials of Henlius’ Innovative Products Released at 2023 ESMO Asia (Henlius Press Release) - P2 | N=156 | NCT04976647 | Sponsor: Shanghai Henlius Biotech | "Recently, results from four phase 1/2 clinical trials conducted in patients with advanced solid tumours of Henlius' self-developed novel products...were released as poster presentations at...ESMO Asia Congress 2023....HLX10HLX07-sqNSCLC-201:...As of 27 June 2023, 12 patients were enrolled and randomly assigned to group A (n=6) and group B (n=6) in part 3....With a median follow-up of 3.5 months, investigator-assessed unconfirmed ORR per RECIST 1.1 was 83.3% (95% CI 35.9–99.6) in group A and 66.7% (95% CI 22.3–95.7) in group B. Disease control rate was 100.0% (95% CI 54.1–100.0) in both groups. 2 (33.3%) patients in group A and 1 (16.7%) in group B had serious treatment-emergent adverse events (TEAEs)."

P2 data • Lung Non-Small Cell Squamous Cancer

Efficacy and safety of HLX07 monotherapy in advanced cutaneous squamous cell carcinoma: An open-label, multicentre phase II study (ESMO Asia 2023) - P2 | "No TRAE leading to death was reported. Conclusions HLX07 monotherapy demonstrated encouraging antitumour efficacy and was well-tolerated in patients with advanced CSCC."

Clinical • Metastases • Monotherapy • P2 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Results from Four Phase 1/2 Clinical Trials of Henlius’ Innovative Products Released at 2023 ESMO Asia (Henlius Press Release) - P2 | N=20 | NCT05238363 | Sponsor: Shanghai Henlius Biotech | "Recently, results from four phase 1/2 clinical trials conducted in patients with advanced solid tumours of Henlius' self-developed novel products...were released as poster presentations at...ESMO Asia Congress 2023....HLX07-CSCC201:...As of 2 July 2023, 31 patients were enrolled and assigned to group A (n=21) and group B (n=10) in part 1....Among the 29 efficacy evaluable patients (21 ingroup A and 8 in group B), the median follow-up duration was 9.6 months and 3.1 months in the respective groups. IRRC-assessed unconfirmed ORR was 23.8% (95% CI 8.2–47.2) in group A and 62.5% (95% CI 24.5–91.5) in group B. IRRC-assessed median PFS was 3.6 months (95% CI 1.4–5.9) in group A and not reached in group B. Median OS was not reached in either group."

P2 data • Squamous Cell Skin Cancer

Henlius Announces Upcoming Mini Oral Presentation and Five Posters at the ESMO Asia 2023 (Henlius Press Release) - "From 1 to 3 December 2023, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), and HLX26 (anti-LAG-3 mAb). Notable among them is the updated analysis of HLX208-LCH/ECD201 study, the phase 2 study of HLX208 in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harbouring BRAFV600E mutation...and the results from this updated analysis were selected for a mini oral presentation. Moreover, results from the Asian subgroup of the pivotal phase 3 study (ASTRUM-004) of serplulimab in treating squamous non-small cell lung cancer (sqNSCLC)...will be presented in the form of a poster presentation....The company will also present data from four other clinical studies in poster..."

Clinical data • Non Small Cell Lung Cancer

Safety and tolerability of HLX07 combined with chemotherapy in patients with advanced solid tumors. (ASCO 2023) - P1/2 | " As of August 28, 2022, 56 patients were enrolled; 21 received HLX07 with gemcitabine and cisplatin, 21 received HLX07 with paclitaxel and carboplatin (n = 3 for HLX07 400 and 600 mg, n = 15 for HLX07 800 mg for each chemo-regimen), and 14 received HLX07 with mFOLFOX6 (n = 3 for HLX07 400 and 600 mg, n = 8 for HLX07 800 mg)... HLX07 was safe and well tolerated when combined with chemotherapy in patients with advance solid tumors. Clinical trial information: NCT03577704. >"

Clinical • Metastases • Gastrointestinal Disorder • Hematological Disorders • Oncology • Solid Tumor

A phase 2 study of HLX07 as monotherapy or combination therapy in patients with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma. (ASCO 2023) - P2 | "Patients with no prior systemic antitumor therapy were assigned to group A and given HLX07 1000 mg plus serplulimab 200 mg (anti-PD-1 mAb) and chemotherapy (5-FU 2400 mg/m2 + cisplatin 50 mg/m2), Q2W IV... The encouraging antitumor activity and manageable safety profile support further development of HLX07 as a new treatment option for patients with advanced ESCC, both in first-line and late-line settings. Clinical trial information: NCT05221658."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

HLX07Ib/II: The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=56 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed | N=90 ➔ 56

Enrollment change • Metastases • Trial completion • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CTLA4 • IL2RA • PD-1 • PD-L1 • TNFRSF9

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2023 ➔ Jun 2024

Enrollment open • Metastases • Trial primary completion date • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A phase 2 study of serplulimab plus HLX07 in patients with advanced head and neck tumours (ECHNO-ICHNO 2022) - P2 | "No TEAEs leading to permanent discontinuation of study drugs or death were reported. Conclusion The results above demonstrated a manageable safety profile and encouraging efficacy of serplulimab plus HLX07 in patients with R/M HNSCC who had failed platinum-based chemotherapy, supporting a new treatment option that warrants further investigations."

Clinical • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors (clinicaltrials.gov) - P2 | N=131 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | N=56 ➔ 131 | Trial completion date: Oct 2023 ➔ Jun 2025 | Trial primary completion date: Dec 2022 ➔ May 2024

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-1 • PD-L1

Henlius (02696.HK): Phase 1b/2 clinical study results of HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) combined with chemotherapy in the treatment of advanced solid tumors showed that it was safe and well tolerated (Investing.com) - P1b/2 | N=90 | NCT03577704 | Sponsor: Shanghai Henlius Biotech | "Henlius...announced that recently, the company's self-developed HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) ('HLX07') combined with chemotherapy has been launched in China Completed Phase 1b/2 clinical studies in China (except Hong Kong, Macao and Taiwan, the same below), and demonstrated good safety and tolerability in a Phase 1b/2 clinical study in patients with advanced solid tumors....The trial results showed that HLX07 was safe and well tolerated. During the study, no DLT events related to HLX07 occurred, and the MTD of HLX07 combined with different chemotherapy regimens was not reached."

P1/2 data • Oncology • Solid Tumor

Henlius Received IND Approval from US FDA for HLX07 in CSCC patients (Henlius Press Release) - "Shanghai Henlius Biotech, Inc...announced that the investigational new drug (IND) application for its HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)."

IND • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer