- Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma
- Tafinlar + Mekinist remains an effective treatment option based on previously reported large, Phase III clinical trials1,2
- Spartalizumab development program continues, investigating the immunotherapy in combination with other anti-cancer agents
BASEL, Switzerland I August 22, 2020 I Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar® (dabrafenib) and Mekinist® (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar + Mekinist alone3.
“While the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar + Mekinist for these patients,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “Novartis remains committed to melanoma patients through ongoing research, and we continue to deliver the approved combination therapy Tafinlar + Mekinist to patients around the world. We extend our gratitude to the patients and investigators who participated in the COMBI-i study. Their partnership has expanded our understanding of spartalizumab and its potential role in future cancer treatments.”
Novartis and the COMBI-i study investigators will continue to review the data to learn more from the results, which are expected to be submitted for presentation at a future medical meeting. Novartis remains committed to exploring new uses for immunotherapy in cancer treatment, including the ongoing development of spartalizumab, across a range of tumor types.
About the COMBI-i Study3
COMBI-i was a randomized, double-blind, placebo-controlled, Phase III study comparing the combination of anti-PD1 spartalizumab with Tafinlar (dabrafenib) and Mekinist (trametinib) versus the combination of placebo with Tafinlar and Mekinist. The study was conducted among previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma. The COMBI-i study was conducted in three parts. Results reported today are from part 3 of the trial.
About Spartalizumab (PDR001)
Spartalizumab is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development program continues investigating the immunotherapy across a range of tumor types.
About Tafinlar + Mekinist Combination
Tafinlar and Mekinist are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:
- That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
- That has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene
Tafinlar and Mekinist are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.
Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal “BRAF V600E” gene.
Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC):
- That has spread to other parts of the body and you have no satisfactory treatment options, and
- That has a certain type of abnormal “BRAF” gene
Tafinlar, in combination with Mekinist, should not be used to treat people with wild-type BRAF melanoma. Mekinist should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.
Your health care provider will perform a test to make sure that Tafinlar and Mekinist , in combination, are right for you.
It is not known if Tafinlar and Mekinist are safe and effective in children.
Please see full Prescribing Information for Tafinlar at https://www.novartis.us/sites/www.novartis.us/files/tafinlar.pdf
and Mekinist at https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf.
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com“>media.relations@novartis.com
References
- Hauschild A, et al. Long-term benefit of adjuvant dabrafenib + trametinib (D+T) in patients (pts) with resected stage III BRAF V600–mutant melanoma: 5-year analysis of COMBI-AD. Abstract #10001. 2020 American Society of Clinical Oncology Annual Meeting, May 29-June 2, Chicago, IL.
- Robert C, et al. Five-Year Outcomes with First-Line Dabrafenib plus Trametinib in Metastatic Melanoma. The New England Journal of Medicine. 2019.
- ClinicalTrials.gov. A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (COMBI-i). https://clinicaltrials.gov/ct2/show/NCT02967692.
SOURCE: Novartis
Post Views: 20
- Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma
- Tafinlar + Mekinist remains an effective treatment option based on previously reported large, Phase III clinical trials1,2
- Spartalizumab development program continues, investigating the immunotherapy in combination with other anti-cancer agents
BASEL, Switzerland I August 22, 2020 I Novartis announced today that the Phase III COMBI-i study evaluating the investigational immunotherapy spartalizumab (PDR001), in combination with the targeted therapies Tafinlar® (dabrafenib) and Mekinist® (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma, compared to Tafinlar + Mekinist alone3.
“While the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar + Mekinist for these patients,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “Novartis remains committed to melanoma patients through ongoing research, and we continue to deliver the approved combination therapy Tafinlar + Mekinist to patients around the world. We extend our gratitude to the patients and investigators who participated in the COMBI-i study. Their partnership has expanded our understanding of spartalizumab and its potential role in future cancer treatments.”
Novartis and the COMBI-i study investigators will continue to review the data to learn more from the results, which are expected to be submitted for presentation at a future medical meeting. Novartis remains committed to exploring new uses for immunotherapy in cancer treatment, including the ongoing development of spartalizumab, across a range of tumor types.
About the COMBI-i Study3
COMBI-i was a randomized, double-blind, placebo-controlled, Phase III study comparing the combination of anti-PD1 spartalizumab with Tafinlar (dabrafenib) and Mekinist (trametinib) versus the combination of placebo with Tafinlar and Mekinist. The study was conducted among previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma. The COMBI-i study was conducted in three parts. Results reported today are from part 3 of the trial.
About Spartalizumab (PDR001)
Spartalizumab is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor. Its development program continues investigating the immunotherapy across a range of tumor types.
About Tafinlar + Mekinist Combination
Tafinlar and Mekinist are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:
- That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
- That has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene
Tafinlar and Mekinist are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.
Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal “BRAF V600E” gene.
Tafinlar and Mekinist are prescription medications that can be used in combination to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC):
- That has spread to other parts of the body and you have no satisfactory treatment options, and
- That has a certain type of abnormal “BRAF” gene
Tafinlar, in combination with Mekinist, should not be used to treat people with wild-type BRAF melanoma. Mekinist should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma and it did not work or is no longer working.
Your health care provider will perform a test to make sure that Tafinlar and Mekinist , in combination, are right for you.
It is not known if Tafinlar and Mekinist are safe and effective in children.
Please see full Prescribing Information for Tafinlar at https://www.novartis.us/sites/www.novartis.us/files/tafinlar.pdf
and Mekinist at https://www.novartis.us/sites/www.novartis.us/files/mekinist.pdf.
About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com“>media.relations@novartis.com
References
- Hauschild A, et al. Long-term benefit of adjuvant dabrafenib + trametinib (D+T) in patients (pts) with resected stage III BRAF V600–mutant melanoma: 5-year analysis of COMBI-AD. Abstract #10001. 2020 American Society of Clinical Oncology Annual Meeting, May 29-June 2, Chicago, IL.
- Robert C, et al. Five-Year Outcomes with First-Line Dabrafenib plus Trametinib in Metastatic Melanoma. The New England Journal of Medicine. 2019.
- ClinicalTrials.gov. A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (COMBI-i). https://clinicaltrials.gov/ct2/show/NCT02967692.
SOURCE: Novartis
Post Views: 20
