Verastem Oncology Boosts Ovarian Cancer Treatment with Positive Phase 2 RAMP-201 Trial Results

Verastem Oncology, a biopharmaceutical company developing cancer treatments, today reports positive interim data for avutometinib (VS-6766) from Part A of the ongoing RAMP 201 Phase 2 study evaluating the safety and efficacy for recurrent low-grade serous ovarian cancer (LGSOC) treatment. Combination of avutometinib with defactinib declared as go forward treatment regimen in LGSOC program. After a productive discussion with the US FDA, the company is also offering a regulatory update.

Publish Date: 24-01-2023 Source: Verastem Oncology

Ovarian cancer is a type of malignancy that occurs in women. The majority of ovarian cancers, up to 90%, originate from the epithelial cells of the ovary. These cancers can be further classified into subtypes based on their histological and immunohistochemical characteristics, with the most common subtypes being high-grade serous (70%), low-grade serous, high-grade endometrioid, low-grade endometrioid, clear cell, and mucinous carcinomas. Low-grade serous carcinoma of the ovary or peritoneum (LGSC) is a rare subtype, accounting for between 5 and 8% of all ovarian carcinomas. LGSC can develop from a precursor lesion known as a serous borderline ovarian tumor (SBOT) or a de novo malignancy in the ovary or peritoneum. Patients with LGSC may present with non-specific symptoms such as abdominal discomfort, bloating, dyspnea, dyspepsia, and changes in bowel movement patterns. Alternatively, it may arise from the malignant transformation of a borderline ovarian tumor. LGSOC is characterized by being WT1 positive (95%), p53 wild-type (90%), ER-positive (57%), and PR positive (78%). Additionally, LGSOC typically presents with activating mutations in the RAS-RAF-MEK-ERK pathway. The neoplasm usually appears as a solid cystic mass involving the ovarian surface and parenchyma, with sizes ranging from 0.2 cm to over 20 cm. Bilaterality is present in approximately 50% of cases. The contents of the tumor are typically serosanguineous or watery and straw-coloured and less frequently mucinous. Patients with low-grade serous carcinoma tend to be younger than those with high-grade tumors, with a mean age of 45–57 years and 55–65 years, respectively.

In China, the ovarian cancer incidence rate was estimated to be 4.2 per 100,000.

However, the current Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Onapristone ER + Anastrozole, Ribociclib and Letrozole, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Recurrent LGSOC treatment. The key companies in the advanced development stage are Context Therapeutics Inc., Gynecologic Oncology Group, etc., targeting LGSOC.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

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