UNLOXCYT is the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma
WALTHAM, MA, USA I December 13, 2024 I Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (“PD-L1”) blocking antibody to receive FDA marketing approval for this indication.
The recommended commercial dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.
“Today’s FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “This approval marks Checkpoint’s transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (“PD-1”), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (“ADCC”), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC.”
“cSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis. cSCC remains a disease with a significant need for more effective and tolerable treatment options, particularly for patients with concomitant hematological malignancies, solid organ transplant recipients, or a history of autoimmune disorders,” stated Emily Ruiz, M.D., M.P.H., Academic Director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital, Director of the High-Risk Skin Cancer Clinic at Dana Farber Cancer Center, and Associate Professor of Dermatology at Harvard Medical School. “UNLOXCYT is the first FDA-approved PD-L1–blocking antibody to demonstrate clinically meaningful objective response rates with durable responses in advanced cSCC. With its dual mechanisms of action and compelling safety profile, this promising drug will provide U.S. oncologists with an important new immunotherapy option for the treatment of cSCC.”
FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC.
“We are excited about the approval of UNLOXCYT and are currently developing a commercial launch plan. We want to thank the patients, physicians, nurses, and clinical coordinators for their support and participation in our clinical program, and the FDA for their collaboration throughout this process,” concluded Mr. Oliviero.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (“cSCC”) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population in particular represents a challenging target in the treatment of advanced cSCC, as patients present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment.
About UNLOXCYT™ (cosibelimab-ipdl)
UNLOXCYT is a human immunoglobulin G1 (“IgG1”) monoclonal antibody that binds PD-L1 and blocks the interaction between PD-L1 and its T cell receptors, PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce ADCC.
INDICATION and IMPORANT SAFETY INFORMATION
INDICATION
UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
Please see full Prescribing Information.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a commercial-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint has received approval from the U.S. FDA for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Additionally, Checkpoint is evaluating its lead investigational small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.
SOURCE: Checkpoint Therapeutics
Post Views: 112
UNLOXCYT is the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma
WALTHAM, MA, USA I December 13, 2024 I Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (“PD-L1”) blocking antibody to receive FDA marketing approval for this indication.
The recommended commercial dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.
“Today’s FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “This approval marks Checkpoint’s transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (“PD-1”), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (“ADCC”), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC.”
“cSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis. cSCC remains a disease with a significant need for more effective and tolerable treatment options, particularly for patients with concomitant hematological malignancies, solid organ transplant recipients, or a history of autoimmune disorders,” stated Emily Ruiz, M.D., M.P.H., Academic Director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital, Director of the High-Risk Skin Cancer Clinic at Dana Farber Cancer Center, and Associate Professor of Dermatology at Harvard Medical School. “UNLOXCYT is the first FDA-approved PD-L1–blocking antibody to demonstrate clinically meaningful objective response rates with durable responses in advanced cSCC. With its dual mechanisms of action and compelling safety profile, this promising drug will provide U.S. oncologists with an important new immunotherapy option for the treatment of cSCC.”
FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC.
“We are excited about the approval of UNLOXCYT and are currently developing a commercial launch plan. We want to thank the patients, physicians, nurses, and clinical coordinators for their support and participation in our clinical program, and the FDA for their collaboration throughout this process,” concluded Mr. Oliviero.
About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma (“cSCC”) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation. Important risk factors for cSCC include chronic ultraviolet exposure and immunosuppressive conditions. While most cases are localized tumors amenable to curative resection, each year approximately 40,000 cases become advanced and an estimated 15,000 people in the United States die from this disease. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear. The immune-suppressed population in particular represents a challenging target in the treatment of advanced cSCC, as patients present with a more aggressive disease and with a higher risk of developing immune-related toxicities from checkpoint inhibitor treatment.
About UNLOXCYT™ (cosibelimab-ipdl)
UNLOXCYT is a human immunoglobulin G1 (“IgG1”) monoclonal antibody that binds PD-L1 and blocks the interaction between PD-L1 and its T cell receptors, PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce ADCC.
INDICATION and IMPORANT SAFETY INFORMATION
INDICATION
UNLOXCYT (cosibelimab-ipdl) is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
Please see full Prescribing Information.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a commercial-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint has received approval from the U.S. FDA for UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Additionally, Checkpoint is evaluating its lead investigational small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.
SOURCE: Checkpoint Therapeutics
Post Views: 112
