89% estimated event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo prior to surgery in a Phase 2 trial
No disease recurrence among the 51% of patients who experienced a pathologic complete response in the primary analysis
TARRYTOWN, NY, USA I October 21, 2023 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.
“Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation. Additionally, risk of recurrence and death is a consideration for these patients,” said Neil D. Gross, M.D., F.A.C.S., Director of Clinical Research, Department of Head and Neck Surgery at the University of Texas MD Anderson Cancer Center and principal investigator of the trial. “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma. These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
The multicenter, single-arm Phase 2 trial included two parts. In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery. Per the primary analysis presented at ESMO 2022 and published in the New England Journal of Medicine, there was a 63.3% (n=50) combined pathologic response rate. This included a 50.6% (n=40) pathologic complete response rate (pCR; 0% residual viable tumor) and a 12.7% (n=10) major pathologic response rate (MPR; >0% and ≤10% residual tumor cells). In Part 2, the post-surgical part of the trial, patients who completed curative intent surgery (n=70), received an investigator’s choice of Libtayo, radiation or observation.
The presentation at this year’s ESMO shared secondary survival endpoints among all 79 patients in the trial, continuing to demonstrate encouraging outcomes at one-year (median duration of follow-up: 19 months; range: 1-30 months), including:
- 89% event-free survival rate (95% confidence interval [CI]: 79%-94%) at one year, per Kaplan-Meier estimates, with the median not reached
- No disease recurrence among patients who achieved a pCR (n=40). Among those achieving an MPR, 9 of 10 remained disease-free at one year
- 92% overall survival rate (95% CI: 83%-96%) at one year, per Kaplan-Meier estimates, with the median not reached
Among all patients, adverse events (AE) of any grade occurred in 89% of patients, with 19% being ≥grade 3, and one death due to worsening congestive heart failure considered possibly related to treatment. Among those who received adjuvant Libtayo in Part 2 of the trial (n=16), there were two grade 3 serious AEs including worsening cardiomyopathy and hypophysitis (n=1 each) and no deaths considered related to treatment.
“The primary analysis of this Phase 2 trial demonstrated greater than 60% response rates, and it is encouraging that Libtayo may have utility in this earlier stage of cutaneous squamous cell carcinoma,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “These new data add to the growing body of evidence for Libtayo in this investigational setting where high unmet patient need remains.”
A separate ongoing global Phase 3 trial is investigating Libtayo in the adjuvant CSCC setting for patients at heightened risk (i.e., due to involvement of multiple lymph nodes, extension of cancer through the lymph node capsule, perineural invasion) for recurrence after surgery and radiotherapy.
The potential use of Libtayo described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication.
About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.
Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.
To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced CSCC and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron.
In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:
- People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
- People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
- Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
- LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
It is not known if Libtayo is safe and effective in children.
Please see full Prescribing Information, including Medication Guide.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
About Regeneron
Regeneron is a leading biotechnology company that invents, develops, and commercializes life- transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron’s laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about Regeneron, please visit www.regeneron.com or follow Regeneron on LinkedIn.
SOURCE: Regeneron Pharmaceuticals
Post Views: 201
89% estimated event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo prior to surgery in a Phase 2 trial
No disease recurrence among the 51% of patients who experienced a pathologic complete response in the primary analysis
TARRYTOWN, NY, USA I October 21, 2023 I Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® (cemiplimab) as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). The results from an international Phase 2 trial were presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.
“Advanced, resectable cutaneous squamous cell carcinoma can lead to reduced patient function and quality of life following the cumulative effects of treatment, typically surgery and radiation. Additionally, risk of recurrence and death is a consideration for these patients,” said Neil D. Gross, M.D., F.A.C.S., Director of Clinical Research, Department of Head and Neck Surgery at the University of Texas MD Anderson Cancer Center and principal investigator of the trial. “Results from both the single-institution pilot trial and the multi-center Phase 2 trial found neoadjuvant cemiplimab was highly active in patients with resectable cutaneous squamous cell carcinoma. These robust responses were durable, translating into event-free survival for the vast majority of patients at one and two years.”
The multicenter, single-arm Phase 2 trial included two parts. In Part 1, patients (n=79) received Libtayo 350 mg every three weeks for up to four doses, followed by curative-intent surgery. Per the primary analysis presented at ESMO 2022 and published in the New England Journal of Medicine, there was a 63.3% (n=50) combined pathologic response rate. This included a 50.6% (n=40) pathologic complete response rate (pCR; 0% residual viable tumor) and a 12.7% (n=10) major pathologic response rate (MPR; >0% and ≤10% residual tumor cells). In Part 2, the post-surgical part of the trial, patients who completed curative intent surgery (n=70), received an investigator’s choice of Libtayo, radiation or observation.
The presentation at this year’s ESMO shared secondary survival endpoints among all 79 patients in the trial, continuing to demonstrate encouraging outcomes at one-year (median duration of follow-up: 19 months; range: 1-30 months), including:
- 89% event-free survival rate (95% confidence interval [CI]: 79%-94%) at one year, per Kaplan-Meier estimates, with the median not reached
- No disease recurrence among patients who achieved a pCR (n=40). Among those achieving an MPR, 9 of 10 remained disease-free at one year
- 92% overall survival rate (95% CI: 83%-96%) at one year, per Kaplan-Meier estimates, with the median not reached
Among all patients, adverse events (AE) of any grade occurred in 89% of patients, with 19% being ≥grade 3, and one death due to worsening congestive heart failure considered possibly related to treatment. Among those who received adjuvant Libtayo in Part 2 of the trial (n=16), there were two grade 3 serious AEs including worsening cardiomyopathy and hypophysitis (n=1 each) and no deaths considered related to treatment.
“The primary analysis of this Phase 2 trial demonstrated greater than 60% response rates, and it is encouraging that Libtayo may have utility in this earlier stage of cutaneous squamous cell carcinoma,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “These new data add to the growing body of evidence for Libtayo in this investigational setting where high unmet patient need remains.”
A separate ongoing global Phase 3 trial is investigating Libtayo in the adjuvant CSCC setting for patients at heightened risk (i.e., due to involvement of multiple lymph nodes, extension of cancer through the lymph node capsule, perineural invasion) for recurrence after surgery and radiotherapy.
The potential use of Libtayo described above is investigational, and its safety and efficacy has not been evaluated by any regulatory authority for this indication.
About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.
Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.
To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced basal cell carcinoma (BCC), advanced CSCC and advanced non-small cell lung cancer (NSCLC), as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron.
In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). Outside of the U.S., the generic name of Libtayo in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:
- People with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
- People with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
- Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
- LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
It is not known if Libtayo is safe and effective in children.
Please see full Prescribing Information, including Medication Guide.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®, Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
About Regeneron
Regeneron is a leading biotechnology company that invents, develops, and commercializes life- transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron’s laboratories. Regeneron’s medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about Regeneron, please visit www.regeneron.com or follow Regeneron on LinkedIn.
SOURCE: Regeneron Pharmaceuticals
Post Views: 201
