dm+d

31310911000001101

New Medicines

CotellicMetastatic or unresectable locally advanced malignant melanoma, BRAFv600 mutation-positive - first-line in combination with atezolizumab and vemurafenib

Information

Cotellic
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Dec 21Development of the NICE TA for this indication was previously suspended in Jan 20; assume company currently has no plans to develop this indication for the UK. No plans for EU filing stated in company pipeline [11,12].
Jul 20US FDA approves atezolizumab in combination with cobimetinib and vemurafenib for the treatment of BRAF V600 mutation-positive advanced melanoma. The approval was based on the results from PIII IMspire 150 trial and following priority review. The review was also conducted under project orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners [9].
May 20Filed in the US [8].
Oct 19Filings will now be in 2020 [5].
Feb 17EU & US filings planned for 2019 or later [2].

Category

MEK inhibitor
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population. It has been estimated that the lifetime risk of developing malignant melanoma in 2010 was 1 in 55 for men and 1 in 56 for women in the UK [1].
Metastatic or unresectable locally advanced malignant melanoma, BRAFv600 mutation-positive - first-line in combination with atezolizumab and vemurafenib
Oral

Further information

Yes

Trial or other data

Nov 20PIII IMspire150 TRILOGY is continuing to collect data and due to complete in Jul 23 [10].
Mar 20Recruitment complete in PIII IMspire150 TRILOGY [4].
Dec 19Primary endpoint met in IMspire150 TRILOGY [7].
Oct 19PIII IMspire150 TRILOGY completes collection of primary outcome data [6].
Mar 17PIII IMspire150 TRILOGY (NCT02908672) is recruiting patients in the US, EU (including UK) and other sites globally. Collection of primary outcome data (PFS) is expected to complete in Nov 19 [3].
Jan 17First patient enrolled in the PIII IMspire150 TRILOGY study. 500 patients will be randomised to atezolizumab plus cobimetinib plus vemurafenib or placebo plus cobimetinib plus vemurafenib [2].