High-risk stage 3 melanoma postoperative auxiliary treatment! The results of Novart's Tafinlar and Mekinist were announced.

COMBI-AD is the first study to demonstrate that the use of targeted therapies to aid the treatment of high-risk Stage III BRAF mutant melanoma has shown a five-year relapse-free benefit: the Tafinlar-Mekinist targeted combination reduces the risk of disease recurrence or death by 49% compared to placebos.
data also show that the Tafinlar-Mekinist targeted combination also improves the survival rate of non-far-end transfers, which is a secondary endpoint of the study.
, more than 285,000 cases of melanoma are diagnosed each year, about half of them with BRAF mutations.
stage III melanoma patients who undergo surgical removal may be at risk of recurrence because melanoma cells may remain in the body after surgery.
studies have shown that most relapses usually occur within five years in patients with high-risk stage III melanoma.
new findings from COMBI-AD add to the growing body of evidence that Tafinlar-Mekinist has significant clinical value in assisted treatment of patients with high-risk Stage III BRAF mutant melanoma.
Jeff Legos, Senior Vice President of Oncology and Head of Oncology Drug Development at Novarma, said, "For patients with high-risk Stage III melanoma, achieving the goal of not relapsing for five years is a far-reaching moment.
target combination of Tafinlar and Mekinist will help patients and clinicians reimagine the possibility of treatment for advanced melanoma.
proud of the far-reaching and lasting benefits demonstrated by COMBI-AD and thank the patients, researchers and their families who participated in this clinical trial.
" COMBI-AD is a two-arm, randomized, double-blind, placebo-controlled, critical Phase III study that included 870 patients who had completed surgery to completely remove and did not receive anti-cancer treatment, were histologically diagnosed, were BRAF V600E/K mutant-positive, and were at high risk (IIIa phase ( lymph node metastasis of 1mm), IIIb or IIIc) for melanoma.
, patients were randomly assigned to receive a combination therapy of Tafinlar (150mg BID) and Mekinist (2mg QD) or a corresponding placebo (n=432) for postoperative ancillary therapy for up to one year.
study, melanoma staging was evaluated according to AJCC Guidelines 7, with the primary endpoint being no recurrence period (RFS), and the secondary endpoints including total lifetime (OS), no remote transfer lifetime, no recurrence analysis, and safety.
5 years (60 months) follow-up results, from a forward-looking analysis of 870 patients with BRAF V600 mutant melanoma who were treated with Tafinlar-Mekinist, represented the longest follow-up and largest data set in the group of patients with stage III melanoma receiving targeted complementary treatment.
results showed that at the end of the five-year data period, 52 percent (95 percent CI: 48-58 percent) of the Tafinlar-Mekinist treatment group survived and did not relapse, and 36 percent of the placebo group (95 percent CI:32-41).
(2) The medium RFS (i.e., the length of time that 50% of patients survived and had no recurrence) in the Tafinlar-Mekinist treatment group had not yet been reached (NR; 95% CI: 47.9 months-NR) and the middle RFS in the placebo group was 16.6 months (95% CI: 12.7-22.1 months).
(3) reduced the risk of recurrence or death by 49% (HR-0.51; 95% CI: 0.42,0.61) compared to placebo.
subgroup analysis showed that the RFS benefits for all sub-periods (IIIa/b/c) were similar based on the AJCC-7 phased standard assessment.
patients treated with Tafinlar and Mekinist, the five-year no-distance transfer survival rate (DMFS) was 65% (95% CI: 61-71%), and the placebo group was 54% (95% CI, 49-60%).
currently, comBI-AD studies are evaluating the secondary endpoint of total lifetime (OS), and OS analysis from the first interim analysis shows a three-year OS rate of 86 percent in the Tafinlar-Mekinist treatment group and 77 percent in the placebo group.
results showed that the Tafinlar-Mekinist combined therapy was more beneficial than the placebo, but did not meet the pre-defined threshold of significantity of p-0.000019.
all patients were treated during long follow-up.
there was no clinically significant difference in the rate or severity of serious adverse events reported during follow-up by the Tafinlar-Mekinist group and the placebo group.
estimates that about 285,000 new cases of melanoma (stage 0-IV) are diagnosed globally each year, about half of which carry BRAF mutations, and genetic testing can determine whether a BRAF mutation exists in tumors.
one way to stage melanoma is based on the degree of metastasis.
stage III melanoma, the tumor has spread to the local lymph nodes, and the risk of recurrence or metastasis is higher.
phase III melanoma patients have a high risk of recurrence after surgery to remove melanoma because cancer cells may still remain in the body.
, the recurrence of stage III melanoma occurs mostly within 5 years.
treatment for patients with high-risk melanoma can help reduce the risk of recurrence.
Tafinlar and Mekinist are both targeted anti-cancer drugs that target different kinases in the serine/suline kinase family in the RAS/RAF/MEK/ERK signaling circuit, respectively, and the abnormal activation of the signaling path is thought to play an important role in the development of melanoma and other types of cancer.
that Tafinlar and Mekinist combined to slow tumor growth more effectively than individual drugs.
, Novart is currently working on a global clinical project to evaluate the Tafinlar-Mekinist combination to treat a range of types of tumors.
The approved adaptations to the Tafinlar-Mekinist combination include: (1) treatment of patients with BRAF V600 mutation III removable, non-removable or metastasis melanoma;
addition, Tafinlar and Mekinist have been approved by several countries around the world as a single drug to treat non-removable or metastasis melanoma patients with BRAF V600 mutations.
original origin: Novartis Tafinlar® and Mekinist®sstr. long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM.