Novartis’ Tafinlar/Mekinist combo improves five-year relapse-free survival in new Phase 3 data
pharmafile | September 17, 2020 | News story | Research and Development | Novartis, Tafinlar, mekinist, melanoma
Novartis has unveiled promising new Phase 3 data for its combination of Tafinlar (dabrafenib) with Mekinist (trametinib) in the treatment of resected, stage 3 BRAF V600-mutated melanoma. The data was published in The New England Journal of Medicine following their presentation at the 2020 ASCO Virtual Scientific Programme.
It was found that 52% of patients receiving the combo therapy survived relapse-free for five years, while only 36% of placebo patients achieved the same. This benefit was shown to be “generally similar” across all the study’s substages, according to AJCC-7 criteria.
Median relapse-free survival was recorded as 16.6 months in the placebo group, but was not reached in the combo therapy group. The combo therapy was also shown to reduce the risk of mortality or relapse by 49% over placebo.
In terms of secondary endpoints, the study found the five-year distant metastasis-free survival (DMFS) rate in the combo therapy group to be 65%, superior to the 54% recorded in the placebo group.
Furthermore, on first interim analysis the combo therapy’s three-year overall survival rate was shown to be 86% compared to 77% with placebo, with studies ongoing to observe this benefit further.
“Reaching the five year mark without relapse is a profound moment for a patient living with high-risk, stage 3 melanoma,” said Dr Jeff Legos, Senior Vice President, Head of Oncology Drug Development at Novartis. “Tafinlar plus Mekinist has helped patients and clinicians reimagine what is possible for patients living with advanced melanoma. We are proud of the deep and durable benefit demonstrated in COMBI-AD and remain grateful to the patients, investigators and their families who participated in this clinical trial.”
Matt Fellows
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