The results will be presented at an upcoming medical meeting and discussed with health authorities around the world, including the U.S. FDA and the EU Medicines Agency.
The IMspire 150 Trial
The IMspire 150 trial is a phase 3, multi-center, double-blind, placebo-controlled randomized study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. In the study a comparison has been made between the efficacy and safety of atezolizumab plus cobimetinib and vemurafenib and the combination of placebo plus cobimetinib and vemurafenib.
- The primary endpoint of the study: Investigator-assessed PFS.
- Key secondary endpoints of the study: Include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.
When diagnosed early melanoma is generally a curable disease. Most people, however, who have advanced melanoma, have a poor prognosis. The American Cancer Society estimates there will be more than 96,000 new cases of melanoma and 7,000 melanoma deaths this year in the United States.
In recent years there have been significant improvements in treating advanced melanoma, and people with the disease have more options. However, advanced cases continue to be serious health issues with a high medical need.
About Exelixis/Genentech Collaboration
Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006 Exelixis entered into a worldwide collaboration agreement with Genentech, under the terms Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib.
This is a definite piece of good news for patients with previously untreated BRAF V600 mutation-positive advanced melanoma. The successful combination offers an unmet need required for patients with advanced skin cancer.
This is positive news for both Genentech and Exelixis as well. The news confirms our conviction that Exelixis enjoys strong scientific fundamentals with professional and capable management. Investors should make themselves aware of the terms of the collaboration in which Exelixis is entitled to an equal initial share of U.S. profits and losses, which will decrease only with the increase in product sales.
Outside of the United States Exelixis is eligible to receive royalties on the sales of the combination.
EXEL is under pressure by the sell-side. We consider it undervalued and we know that sooner or later the firm’s continued accomplishments will boost the stock so it can reach its fair value.
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Exelixis and Genentech (Roche) Combination Beats Untreated BRAF V600-Mutation Positive Advanced Melanoma
Exelixis Positive Results from IMspire 150
Exelixis (EXEL) announced positive results from IMspire 150; the phase 3 trial of atezolizumab (TECENTRIQ®), cobimetinib (COTELLIC®) and vemurafenib (ZELBORAF®) in people with previously untreated BRAF V600 mutation-positive advanced melanoma.
The IMspire150 study met its primary endpoint of progression-free survival (PFS). Adding atezolizumab to cobimetinib and vemurafenib helped reduce the risk of disease worsening or death, compared to placebo plus cobimetinib and vemurafenib.
A significant and clinically meaningful improvement in PFS was demonstrated in IMspire150. The safety profile observed in the trial was consistent with the known safety profiles of the individual medicines.