Exelixis (EXEL) Confirms FDA Approval of COTELLIC in Combination With Vemurafenib to Treat Advanced Melanoma
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Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved COTELLIC™(cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. COTELLIC and vemurafenib are not used to treat melanoma with a normal BRAF gene. COTELLIC is a selective inhibitor of MEK that was discovered by Exelixis and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group. This is the second regulatory approval for COTELLIC, which was first approved in Switzerland in late August 2015.
Genentech sponsored the COTELLIC U.S. New Drug Application (NDA), having led the compound’s development since midway through the initial phase 1 clinical trial. Genentech filed its NDA in December 2014; the FDA accepted the filing and granted it Priority Review in February 2015. Separately, Roche filed a Marketing Authorization Application (MAA) with the European Medicines Agency in late 2014, and the Committee for Medicinal Products for Human Use issued a positive opinion for the MAA in September 2015. Roche anticipates a decision from the European Commission by year-end.
“The approval of COTELLIC for use in combination with vemurafenib is an important milestone for the melanoma community, and also for Exelixis, as it is the second medicine discovered in our laboratories to receive regulatory approval in the United States,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to working with Genentech and Roche to bring this important new treatment option for BRAF V600E and V600K mutation-positive advanced melanoma to patients, physicians, and caregivers.”
The COTELLIC approval is based on data from the phase 3 coBRIM study, which showed COTELLIC plus vemurafenib reduced the risk of disease worsening or death (progression-free survival; PFS) by about half in people who received the combination (HR=0.56, 95 percent CI 0.45-0.70; p<0.001), with a median PFS of 12.3 months for COTELLIC plus vemurafenib compared to 7.2 months with vemurafenib alone. An interim analysis also showed the combination of COTELLIC and vemurafenib helped people live significantly longer (overall survival) than vemurafenib alone (HR=0.63, 95 percent CI 0.47-0.85; p=0.0019). The objective response rate (tumor shrinkage) was higher with COTELLIC plus vemurafenib compared to vemurafenib alone (70 vs. 50 percent; p<0.001), as was the complete response rate (complete tumor shrinkage, 16 vs. 10 percent).
Possible serious side effects with COTELLIC include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of COTELLIC include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. COTELLIC can also cause changes in blood test results.
The final overall survival analysis from the coBRIM trial will be presented at the Society for Melanoma Research 2015 International Congress, which will be held in San Francisco from November 18-21.
In November 2013, Exelixis exercised its option under the 2006 collaboration agreement to co-promote COTELLIC in the United States; accordingly, Exelixis will field 25% of the sales force, closely coordinating its efforts with Genentech. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. The company is also eligible to receive royalties on any sales of the product outside the country, including in Switzerland, where COTELLIC was first approved, and in the European Union, where Roche anticipates a regulatory decision by year-end.
Dr. Morrissey continued: “The approval of COTELLIC represents a major achievement for Exelixis and for all of the employees, past and present, who contributed to the program since its inception. As we enter the commercialization phase of our partnership with Genentech and Roche, our agreement enables Exelixis to participate meaningfully in the product’s introduction and ongoing sales. In the United States, our team is fully prepared to co-promote COTELLIC. Outside of the country, we are eligible to receive royalties on sales. Exelixis is excited to be working with Genentech and Roche to ensure that the commercialization phase of our cobimetinib partnership mirrors the productivity and success seen during COTELLIC discovery and clinical development.”
About COTELLIC™ in Combination with Vemurafenib
COTELLIC™ (cobimetinib) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
COTELLIC and vemurafenib are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal BRAF gene. Found in approximately half of melanomas, mutated BRAF causes abnormal signaling inside cancer cells leading to tumor growth. Vemurafenib is designed to inhibit some mutated forms of BRAF and COTELLIC is designed to inhibit some forms of MEK. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival. When used in combination, COTELLIC and vemurafenib are thought to reduce cancer cell growth longer than with vemurafenib alone. A patient’s healthcare provider will perform a test to make sure COTELLIC and vemurafenib are right for the patient. It is not known if COTELLIC and vemurafenib are safe and effective in children under 18 years of age.
About Melanoma and its BRAF V600 Mutation-Positive Form
Melanoma is the less common, but more serious category of skin cancer that starts in the skin’s pigment producing cells known as melanocytes. According to the American Cancer Society, approximately five percent of skin cancer diagnoses are melanoma, but melanoma accounts for a large majority of skin cancer deaths. In recent years, there have been significant advances in treatment for metastatic melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years. It is projected that approximately half of all melanomas, and eight percent of solid tumors, contain a mutation of the BRAF protein. BRAF is a key component of the RAS-RAF-MEK-ERK pathway involved in normal cell growth and survival. However, mutations that keep the BRAF protein in an active state may cause excessive signaling in the pathway, leading to uncontrolled cell growth and survival.
COTELLIC™ Important Safety Information
Before taking COTELLIC, patients should tell their doctor if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements because some types of medicines will make COTELLIC more harmful or less effective. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.
Patients should avoid sunlight while taking COTELLIC. COTELLIC can make patients’ skin sensitive to sunlight and cause them to burn more easily and get severe sunburns. To help protect against sunburn:
COTELLIC may cause serious side effects, including:
Patients must check their skin and tell their doctor right away about any skin changes, including:
A patient’s healthcare provider should check their skin before they start taking COTELLIC and every two months while taking COTELLIC. A patient’s healthcare provider may continue to check their skin for six months after they stop taking COTELLIC.
The most common side effects of COTELLIC include:
A patient’s healthcare provider will take blood tests while they are taking COTELLIC. The most common changes to blood tests include:
Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.
These are not all the possible side effects of COTELLIC. For more information about side effects, patients should ask their healthcare provider or pharmacist. Patients should call their doctor for medical advice about side effects.
Patients should talk to their doctor for medical advice about side effects. Report side effects to FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
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