Five-year Tafinlar + Mekinist survival data presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine (NEJM)
Results are from a dataset of more than 500 patients over a period of five years with BRAF-mutated metastatic melanoma, a genetic mutation common for this aggressive skin cancer
Dorval, Quebec, June 11, 2019 – Novartis has announced five-year results from the landmark COMBI-d and COMBI-v clinical trials, with first-line treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) analyzing overall and progression-free long-term survival in patients with unresectable or metastatic BRAF-mutation positive melanoma.
The results, from a pooled analysis of 563 patients from the COMBI-d and COMBI-v trials, represents the largest collection of data and longest follow up among patients with advanced melanoma with BRAF V600-mutated unresectable or metastatic melanoma who were treated with Tafinlar + Mekinist. These data were presented at the 2019 ASCO Annual Meeting (Abstract #9507) and published simultaneously in The New England Journal of Medicine1,2.
“This five-year analysis represents the longest follow up for Tafinlar + Mekinist to date and demonstrates the potential for positive impact on long-term patient survival,” said Daniel Hébert Country Medical Head, Oncology, Novartis Pharmaceuticals Canada Inc. “These results are particularly encouraging because historically the prognosis for melanoma has been poor once the disease has metastasized.”
Researchers reported the five-year COMBI-d/v analysis demonstrated1,2
That about one third (34%; 95% CI: 30-38%) of all patients in the pooled analysis who were treated with Tafinlar + Mekinist survived at five years.
Prolongation in progression-free survival (PFS), with about one fifth (19%; 95% CI: 15-22%) of patients treated with Tafinlar + Mekinist showing no sign of disease progression or death at five years.
Five-year overall survival and PFS were similar in the pooled patient population.
About the COMBI-d and COMBI-v studies1,2 COMBI-d is a pivotal Phase III randomized, double-blinded study (NCT01584648) comparing the combination of the BRAF inhibitor, Tafinlar®, and the MEK inhibitor, Mekinist®, to single-agent therapy with Tafinlar and placebo as first-line therapy in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. The study randomized 422 patients from 121 investigative sites.
COMBI-v is a two-arm, open-label, Phase III study comparing the combination of Tafinlar + Mekinist with vemurafenib monotherapy in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma (NCT01597908). The primary endpoint of this study was OS.
The combination of Tafinlar + Mekinist is approved in Canada to treat patients with unresectable or metastatic melanoma who have a BRAF V600 mutation and for the adjuvant treatment of patients with BRAF V600 mutation melanoma and involvement of lymph nodes, following complete surgical removal of the tumours3.
Tafinlar® (dabrafenib) + Mekinist® (trametinib) Important Safety Information The full prescribing information for Tafinlar® and Mekinist® can be found at: www.novartis.ca.
About Novartis Pharmaceuticals Canada Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2018, the company invested $52 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.
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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105,000 people of more than 140 nationalities work at Novartis around the world. Find out more at http://www.novartis.com.
1Paul D. Nathan, et al. Five-year analysis of dabrafenib plus trametinib (D+T) in patients with BRAF V600–mutant unresectable or metastatic melanoma confirms long-term benefit. Abstract #9507. 2019 American Society of Clinical Oncology Annual Meeting, May 31-June 4, Chicago, IL. 2Robert C, et al. Five-Year Outcomes with First-Line Dabrafenib plus Trametinib in Metastatic Melanoma. The New England Journal of Medicine. 2019. 3 Novartis Pharmaceuticals Canada Inc., Tafinlar® and Mekinist® Product Monographs. April 12, 2019 & April 5, 2019.