Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar + Mekinist in advanced melanoma
- 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
- 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
- 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
Anja von Treskow Novartis External Communications +41 79 392 8697 anja.von_treskow@novartis.comEric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.com | Mary Curtin Creaser Novartis Oncology Communications +1 862 345 4102 mary.curtin_creaser@novartis.com |
Central | North America | ||
Samir Shah | +41 61 324 7944 | Sloan Simpson | +1 862 778 5052 |
Thomas Hungerbuehler | +41 61 324 8425 | ||
Isabella Zinck | +41 61 324 7188 | ||
- 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.