QL2107 (pembrolizumab biosimilar) / Qilu Pharma, Cipla - LARVOL DELTA

A Phase 2 Trial of QLC5508 (MHB088C) Plus QL1706 or QL2107 as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (IASLC-WCLC 2026) - "This study aimed to evaluate the efficacy and safety of QLC5508 in combination with QL1706 (iparomlimab and tuvonralimab, a bifunctional antibody targeting PD-1 and CTLA-4) or QL2107 (a pembrolizumab biosimilar) as first-line treatment in patients with ES-SCLC. Conclusions : QLC5508 in combination with QL1706 or QL2107 as first-line treatment showed promising anti-tumor activity and a manageable safety profile in patients with ES-SCLC. The combined regimen of B7H3 ADC plus PD-1 or PD-1/CTLA-4 antibody is a potential therapy for ES-SCLC and worthy of further exploration."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Phase 1b/2 study of anti-CCR8 antibody QLP2117 plus anti-PD-1 antibody QL2107 in patients (pts) with advanced solid tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • CCR8

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Jun 2028 ➔ Jun 2033

Trial completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2028

Minimal residual disease • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-nave Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=556 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) (clinicaltrials.gov) - P=N/A | N=7458 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Sep 2026 ➔ Dec 2025

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTLA4 • PD-1 • PD-L1

Pembrolizumab and Radiation Therapy With or Without Neoadjuvant Doxorubicin and Ifosfamide for the Treatment of High-Risk Resectable Undifferentiated Pleomorphic Sarcoma or Liposarcoma of the Extremity or Trunk Wall (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Ohio State University Comprehensive Cancer Center

New P3 trial • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas (clinicaltrials.gov) - P3 | N=365 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2035 ➔ Apr 2032 | Trial primary completion date: Jun 2035 ➔ Apr 2032

Trial completion date • Trial primary completion date • Liposarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2/3 | N=336 | Not yet recruiting | Sponsor: ECOG-ACRIN Cancer Research Group

New P2/3 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

KEYNOTE-242: Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer (clinicaltrials.gov) - P3 | N=1195 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

ACHIEVE Study: Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial (clinicaltrials.gov) - P3 | N=304 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2035 ➔ Apr 2039 | Trial primary completion date: Jan 2035 ➔ Apr 2039

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

EA8231: A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer (clinicaltrials.gov) - P3 | N=320 | Recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2028 ➔ Dec 2030 | Trial primary completion date: Dec 2028 ➔ Dec 2030

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment (clinicaltrials.gov) - P2 | N=23 | Recruiting | Sponsor: City of Hope Medical Center | Initiation date: Jul 2026 ➔ Oct 2026

Trial initiation date • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Invagen Pharmaceuticals Inc, a wholly owned subsidiary of Cipla Limited…announced that it has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. (hereinafter referred to as Qilu), for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda (pembrolizumab), for the United States (PRNewswire) - "As part of the agreement, Qilu will be responsible for development, regulatory registration and supply of the product while Cipla USA Inc. will be responsible for the commercialization of the asset by leveraging its strong commercial presence in the defined territory."

Licensing / partnership • Solid Tumor

A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Testing the Addition of an Anti-cancer Drug, BAY 1895344, With Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Jan 2027

Trial completion date • Tumor mutational burden • Head and Neck Cancer • Hypopharyngeal Cancer • Laryngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Otorhinolaryngology • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thyroid Gland Carcinoma • CD4

Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=3 | Active, not recruiting | Sponsor: University of Michigan Rogel Cancer Center | Recruiting ➔ Active, not recruiting | N=22 ➔ 3 | Trial completion date: Mar 2030 ➔ Dec 2026 | Trial primary completion date: Mar 2028 ➔ Dec 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Inflammatory Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

Testing the Investigational Medication Pembrolizumab After Kidney Removal for Patients With Non-Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P3 trial • Genito-urinary Cancer • Non Clear Cell Renal Cell Carcinoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (clinicaltrials.gov) - P3 | N=718 | Recruiting | Sponsor: SWOG Cancer Research Network | Not yet recruiting ➔ Recruiting

Enrollment open • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=27 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

ETCTN 10183: Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

SWOG 1512: Pembrolizumab in Treating Patients With Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: May 2026 ➔ May 2027

Trial completion date • Tumor mutational burden • Melanoma • Oncology • Solid Tumor • CD4