Therapy Areas: Oncology
FDA Approves Genentech's Tecentriq plus Cotellic and Zelboraf for People with Advanced Melanoma
3 August 2020 - - The US Food and Drug Administration approved Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines, US-based Genentech said.

The supplemental Biologics License Application for Tecentriq was granted under 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.

The approval is based on results from the Phase III IMspire150 study, in which the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without their disease worsening or death (progression-free survival, PFS), compared to placebo plus Cotellic and Zelboraf (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025).

The most common adverse reactions (rate ≥20%) in patients who received Tecentriq plus Cotellic and Zelboraf were rash, musculoskeletal pain, fatigue, hepatotoxicity, pyrexia, nausea, pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.

This includes studies evaluating Tecentriq both alone and in combination with other medicines.
For those who qualify, Genentech will offer patient assistance programs for people prescribed Tecentriq plus Cotellic and Zelboraf by their doctor through Genentech Access Solutions.

IMspire150 is a Phase III, multi-center, double-blind, placebo-controlled randomized study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma.

The study compared the efficacy and safety of Tecentriq plus Cotellic and Zelboraf to the combination of placebo plus Cotellic and Zelboraf.

The primary endpoint of the study was investigator-assessed PFS. Key secondary endpoints include PFS by an independent review committee, overall survival, objective response rate, duration of response and other safety and pharmacokinetic measures.

Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. When melanoma is diagnosed early, it is generally a curable disease, but most people with 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 advances in treatment for advanced melanoma and people with the disease have more options.

However, it continues to be a serious health issue with a high medical need and a steadily increasing incidence over the past 30 years.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Cotellic is designed to inhibit MEK1/2, proteins in a cell signaling pathway that helps control cell growth and survival. Cotellic, when used in combination with Zelboraf, is approved in the United States and Europe, as well as many countries around the world, for the treatment of people with melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation.

Cotellic was discovered by Exelixis and is being developed by Genentech, a member of the Roche Group, in collaboration with Exelixis.

Zelboraf is a prescription medicine for the treatment of people with melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation.

Zelboraf is designed to inhibit some mutated forms of BRAF, which cause abnormal signaling inside cancer cells leading to tumor growth.

BRAF is a protein in a cell signaling pathway that helps control cell growth and survival. Zelboraf was the first approved product in its class. Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon Inc., the small molecule structure-guided R and D center of the Daiichi Sankyo Group.

Founded more than 40 years ago, Genentech is a biotechnology company. The company is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
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