Unloxcyt (cosibelimab-ipdl) / Sun Pharma - LARVOL DELTA

Efficacy and Safety of Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Update from a Pivotal Open-label Study with a Median Follow-up of ≥2.5 Years (ESMO 2026) - No abstract available

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

Immune Checkpoint Inhibition in Locally Advanced, Recurrent, and Metastatic Cutaneous Squamous Cell Carcinoma. (PubMed, Clin Dermatol) - P3 | "Cemiplimab and pembrolizumab are programmed cell death 1 (PD-1) inhibitors and cosibelimab is a programmed death ligand 1 (PD-L1) inhibitor, all FDA approved for advanced cSCC...Neoadjuvant cemiplimab has generated high pathologic response rates and the randomized phase II MATISSE trial supports continued investigation of neoadjuvant nivolumab with or without ipilimumab. Despite the biologic rationale for biomarker-guided treatment, tumor mutational burden and PD-L1 expression have not shown sufficiently consistent predictable values for clinical selection. Active investigations into the efficacy of ICIs in advanced resectable and unresectable cSCC are rapidly shifting management with evidence revealing promises of greater disease-free survival through neoadjuvant and adjuvant approaches."

Checkpoint inhibition • IO biomarker • Journal • Tumor mutational burden • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation • TMB

Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy (clinicaltrials.gov) - P4 | N=80 | Recruiting | Sponsor: Dana-Farber Cancer Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

A novel oral prodrug (CK301) for effusive feline infectious peritonitis: An open-label study evaluating dose optimization and therapeutic efficacy. (PubMed, Vet Microbiol) - "In this open-label trial, 150 cats with naturally occurring effusive FIP were randomly assigned to receive oral CK301 tablets (Patent WO2023197791) at low, medium, or high doses; placebo; or subcutaneous GS-441524. In conclusion, medium-dose oral CK301 (12.5 mg/kg) significantly prolonged survival, highlighting its potential as a therapeutic option for effusive FIP. It offers a convenient, non-invasive alternative to injectable treatments, provided liver function is closely monitored for potential transaminase elevations."

Journal • Hepatology • Infectious Disease • Liver Failure • Novel Coronavirus Disease

At the ASCO 2026 Annual Meeting, Sun Pharma to Present Pivotal Long-Term Follow-up Data on UNLOXCYT (cosibelimab-ipdl) (PRNewswire) - "In the investigator-reviewed data being presented at ASCO, 64 patients with laCSCC received ≥1 dose of UNLOXCYT...The objective response rate was 50%, including 17 (27%) complete responses and 15 (23%) partial responses...Over a median follow-up of 31 months, responses were durable and the median duration of response was not yet reached."

P2 data • Squamous Cell Skin Cancer

Efficacy and safety of cosibelimab 800 mg every 2 weeks for locally advanced cutaneous squamous cell carcinoma: Updated follow-up from a pivotal study. (ASCO 2026) - P1 | "Responses to treatment with cosibelimab 800 mg Q2W remained robust and durable with stable ORR after continued follow-up in a larger cohort of patients with laCSCC, with no new safety signals identified."

Clinical • Metastases • Hematological Disorders • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Efficacy and Safety of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma: An Expert Consensus Panel. (PubMed, J Drugs Dermatol) - "Available data suggests that cosibelimab is an effective treatment for patients with laCSCC and mCSCC who are not candidates for surgery or radiation. Cosibelimab demonstrates a unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of follow-up."

Journal • Review • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Checkpoint Therapeutics, Inc.

First-in-human • New P1 trial • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=500 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | N=80 ➔ 500 | Trial completion date: Dec 2020 ➔ Mar 2021 | Trial primary completion date: Mar 2019 ➔ Mar 2020

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thoracic Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Trial primary completion date: Mar 2018 ➔ Mar 2019

First-in-human • Trial primary completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=272 | Active, not recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=500 ➔ 272 | Trial completion date: Dec 2024 ➔ Dec 2025

Enrollment change • Enrollment closed • First-in-human • Trial completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=500 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024

First-in-human • Trial completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=500 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Jul 2021 ➔ Nov 2021

First-in-human • Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=500 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2020 ➔ Jul 2021

First-in-human • Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thoracic Cancer • Urothelial Cancer • MSI

CK-301-101: Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (clinicaltrials.gov) - P1 | N=500 | Recruiting | Sponsor: Checkpoint Therapeutics, Inc. | Trial completion date: Mar 2021 ➔ Dec 2021 | Trial primary completion date: Mar 2020 ➔ Dec 2020

First-in-human • Trial completion date • Trial primary completion date • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Melanoma • Merkel Cell Carcinoma • Mesothelioma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Thoracic Cancer • Urothelial Cancer • MSI

Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: Dana-Farber Cancer Institute

New P4 trial • Essential Thrombocythemia • Genetic Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-melanoma Skin Cancer • Oncology • Sezary Syndrome • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation • PD-1

Onco360 Has Been Selected as the National Pharmacy Partner for UNLOXCYT (cosibelimab-ipdl) (GlobeNewswire) - "UNLOXCYT is the first and only PD-L1 immune checkpoint inhibitor approved for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation."

Commercial • Squamous Cell Skin Cancer

Sun Pharmaceutical Industries Limited...announced UNLOXCYT (cosibelimab-ipdl) is now available in the U.S. for healthcare professionals to prescribe for adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation (PRNewswire) - "UNLOXCYT is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy."

Launch US • Squamous Cell Skin Cancer

Cosibelimab: A Novel Therapeutic for Advanced Cutaneous Squamous Cell Carcinoma. (PubMed, J Clin Aesthet Dermatol) - "Additional real-world studies are needed to further evaluate its efficacy and safety. Cosibelimab is a novel immune checkpoint inhibitor and represents a promising therapeutic option for patients with advanced cSCC."

Journal • Review • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

FDA approves label update for UNLOXCYT (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC) (PRNewswire) - "The updated label now incorporates long-term follow-up data from the pivotal CK-301-101 trial, a multicenter, multicohort, open-label study of 109 patients (31 with laCSCC; 78 with mCSCC), which showed patients receiving UNLOXCYT experienced durable clinical responses."

FDA event • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Arsen Osipov | Trial completion date: Dec 2027 ➔ Feb 2027 | Initiation date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Dec 2027 ➔ Feb 2027

Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Immunotherapy in Advanced Cutaneous Squamous Cell Carcinoma: A Retrospective Study of 59 Patients in a Monographic Center (EADV 2025) - "In cases where surgery or radiotherapy is not feasible as curative treatment, immune checkpoint inhibitors, such as anti-PD-1 agents (Cemiplimab, Nivolumab, Pembrolizumab) and anti-PD-L1 agents (Cosibelimab), are the main therapeutic option. Immunotherapy is a safe and effective treatment option for a broad range of patients with advanced cSCC. Our study conducted in routine clinical practice provides valuable insights into treatment response and supports further research into predictive biomarkers and patient stratification strategies."

IO biomarker • Metastases • Retrospective data • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years. (PubMed, J Am Acad Dermatol) - "Cosibelimab demonstrated robust and durable ORRs with increasing CR rates in advanced CSCC and low rates of severe immune-related adverse events."

Journal • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • PD-L1

Fortress Biotech Announces Closing of Sale of Subsidiary Checkpoint Therapeutics (The Manila Times) - "Fortress Biotech, Inc...today announced that its subsidiary, Checkpoint Therapeutics, Inc...has been acquired by Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, 'Sun Pharma')....We are thrilled that our Fortress-founded subsidiary, Checkpoint, closed an exciting deal with Sun Pharma that expedites patient access to FDA approved UNLOXCYT (cosibelimab-ipdl) through their established global commercial organization. This transaction is also another successful milestone for Fortress, as we will receive approximately $28 million shortly after closing and are eligible for a 2.5% royalty on net sales of UNLOXCYT, and up to an additional $4.8 million if the contingent value right (CVR) is achieved."

M&A • Skin Cancer • Squamous Cell Skin Cancer