Abstract No : Presentation LBA45

Indication : Melanoma

Intervention : LGX818 + MEK162

Company : Novartis

Technology : BRAF+MEK Inh

Results:

69 patients were treated in arm A, 71 in arm B and 69 in arm C. At a median follow-up of 17.5 months (IQR 10.2-23.4– d.b.lock July 2020), we report preliminary data of PFS, ORR and safety. mPFS was 15.8 months in Arm A, 7.2 months in Arm B, and 11.4 months in Arm C. In the 3 Arms 1-year PFS was 60%, 43% and 46% and 2-year PFS was 35%, 38% and 39% respectively. ORR was 82.6% (CR 21.7%) in Arm A, 45.1% (CR 15.5%) in Arm B and 78.3% (CR 29.0%) in Arm C. G3/4 toxicity was 49% in Arm A, 73% in Arm B and 51% in Arm C, while G.3/4 treatment-related adverse events were 28%, 54% and 32%. 18 pts were discontinued due to adverse events, 7 in Arm A, 8 in Arm B and 3 in Arm C.

Conclusion:

At a minimum follow up of 1 year, our data confirm what reported in the pivotal studies. Despite the difference in term of mPFS, the 2-yrs PFS rate is similar among the different arms. The study is still ongoing for the completion of the main endpoint (OS).