A rare type of ovarian cancer that grows slowly and responds badly to chemotherapy now has the first treatment approved by the FDA, a combined drug developed by vector oncology to address a path that drives tumor progression.
The approval announced on Thursday covers the treatment of low -grade serous ovarian cancer (LGSOC) driven by a KRAS mutation in adults who have received an earlier systemic therapy. The Verastem medication, a combination of two small molecules formulated as pills taken separately, will be marketed under the Avmapki Fakzynja Co-Pack brand. Verastem expects your new product to get around next week.
Ovarian cancer comes in several different types. High grade serous ovarian cancer (HGSOC) is the most common type, typically diagnosed in women between the ages of 40 and 60. Surgery and chemotherapy are standard treatments for HGSOC. On the contrary, LGSOC is more rarely and the offers diagnosed in younger women, typically between the ages of 20 and 30 or 30 and 60, according to Verastem. The company estimates that 6,000 to 8,000 women in the US live with LGSOC and 1,000 to 2,000 cases are diagnosed every year. After a diagnosis, patients survive a median or 10 years. Surgery, chemotherapy and out of label or hormonal therapies are standard treatments for LGSOC. But this type of cancer does not respond well to these treatments and recurrence is common.
It is estimated that 70% of LGSOC tumors are driven by mopk mutations that regulates a certain process, such as cell growth. Mutations to genes such as race and I can deregulate this route, contributing to the growth of cancer cells. It was thought that the family of ras was Indioscable. In 2021, Amgen Lumakras became the first scratch inhibitor approved by the FDA. This daily pill is approved to treat lung cancer of non -small cells driven by G12C KRAS mutations.
The Avutometinib component of the vervem drug combination is an inhibitor of the small MEK proteins, the proteins we mutter can activate the RAS/MAP route. The Defactinib component of the Verastem drug is an inhibitor of the small molecule of two members of the FAK protein family who play roles in the growth, spread and survival of cancer cells. According to Verastem, this combination is intended to provide a more complete blockade of the aberrant signaling that drives cancer growth and drug resistance of tumors that defend on the RAS/MAPK route.
Verastem evaluated the combination of drugs in a fundamental study of phase 2 that included 57 adults with recurrent LGSOC measurable with Kras mutation. The participants in the open study had at least a previous systemic therapy, including a platinum -based chemotherapy. During the first three weeks of each four -week treatment cycle, the Avutometinib was tasks twice a week, while the defactinib was tasks twice a day. The results showed a general response rate of 44%. The response duration varied from 3.3 months to 31.1 months. The serious complications reported in the study included toxicities in the eyes, skin and liver.
The regulatory decision announced on Thursday is an accelerated approach made under a route that can make a medicine be faster for conditions with few treatments or noisy. The medications approved under this fastest path must confirm their safety and efficiency in a larger phase 3 sthae. This confirmatory study is underway; Verastem estimates the registration at the end of this year.
“The Approval of Avutometinib Plus Defacinib Brigs A Much-Needic Option To Patients and Establishments This Combination As The New Standard of Care for Women With Recurrent Low-Grade Serourian Ovarian Cancer Harboring A Kras Mutation,” Dr. Rachel Grisham, Section Head Head Head, Ovarian Cancer at Memorial AT Memorial Sloan Kettering Cancer Center, and Global Lead main investigation of the Verastem Drug’s Clinical Trials, Said in A Statement Included in the Company’s Ad approval announcement. “I hope to progress the confirmatory essay of Phas 3, disaster 301, where we seek to continue to support the continuous body of research of this combination in women with and without Kras mutation.”
In addition to potentially supporting full approval in LGSOC, Verastem said that phase 3 study could also support the expansion of the combination of drugs to the treatment of LGSOC regardless or the state of Kras mutation. Verastem said that clinical trials sponsored by the researcher are underway evaluating the combination of medications in other gynecological cancers driven by MAPK road mutations. Studies in the middle stage are also placing the evaluation of the combination of medications in non -small cell lung cancer and pancreatic cancer.
At the end of 2024, Vérstem reported that its cash position was $ 88.8 million. Since then, the company has made movements to strengthen its financing in preparation for the marketing of CoPresco Avmapki Fakzynja. In January, Verastem obtained up to $ 150 million in debt financing; At the end of last month, the company raised $ 75 million in a private securities placement.
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