TECENTRIQ + COTELLIC® (cobimetinib) + ZELBORAF® (vemurafenib)

Significantly Improved Progression-Free Survival in 1L BRAF V600+ Unresectable or Metastatic Melanoma 1,3

4.5 months longer median PFS vs placebo + COTELLIC + ZELBORAF

Landmark analyses were not powered to demonstrate statistically significant differences. The PFS rates at 6, 12, and 18 months were estimated with the use of Kaplan-Meier methodology for each treatment arm.

  • Median survival follow-up time: 18.9 months

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TECENTRIQ treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see below and the TECENTRIQ Prescribing Information for additional Important Safety Information.

Prespecified exploratory subgroup analysis of PFS across predefined patient subgroups (N=514) 3,4 

  • These prespecified exploratory subgroup analyses were not powered to demonstrate statistically significant differences between treatment arms

TECENTRIQ + COTELLIC + ZELBORAF provided durable responses 1

  • ORR was 66% (95% CI, 60, 72) vs 65% with placebo + COTELLIC + ZELBORAF (95% CI, 59, 71)†#
    • CR: 16% vs 18%
    • PR: 50% vs 47%

7.9 months longer median DoR 1

Overall survival continues to be evaluated 1
  • At the time of the analysis, median OS was evaluated as part of a prespecified analysis, and the data were not mature
  • Median OS was 28.8 months vs 25.1 months with placebo + COTELLIC + ZELBORAF (HR=0.85; 95% CI, 0.64, 1.11; P=0.2310)

1L=first line; CI=confidence interval; CR=complete response; DoR=duration of response; ECOG=Eastern Cooperative Oncology Group; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; IC=tumor-infiltrating immune cells; LDH=lactate dehydrogenase; NE=not estimable; ORR=overall response rate; OS=overall survival; PD-L1=programmed death-ligand 1; PFS=progression-free survival; PR=partial response; PS=performance status; RECIST=Response Evaluation Criteria In Solid Tumors.
*Stratified by baseline LDH.
As assessed by the investigator, per RECIST v1.1.
Based on the stratified log-rank test.
§The following total number of patients (n) from either treatment arm had unknown or missing subgroup results: ECOG PS (n=<1%), melanoma staging (n=<1%), PD-L1 expression (n=5%), organ involvement (n=<1%), sum of longest diameter (n=<1%), histological subtype (n=<1%), baseline BRAF mutation subtype (n=14%), and distant metastasis (n=<1%).
||Histological subtype at initial diagnosis.
Stage of distant metastasis at study entry.
#Confirmed responses.