Rare Occurring Mutation Alliance (ROMA) Officially Launched to Address Unmet Needs of 'Rare Patients' Within China's Most Common Cancer

On May 13, 2020, the inaugural meeting of the Chinese Rare Mutation Alliance for Lung Cancer was held online, marking the official establishment of China’s first collaborative group dedicated to rare mutations in lung cancer. The Chinese Rare Mutation Alliance for Lung Cancer (Rare Occurring Mutation Alliance, abbreviated as ROMA) was jointly initiated by clinical physicians and pathology experts, in collaboration with diagnostic testing companies and pharmaceutical enterprises, under the guidance of the China Anti-Cancer Association and the Chinese Society of Clinical Oncology (CSCO). Focusing on the current status of diagnosis and treatment for rare lung cancer mutations, ROMA aims to create a complete ecological loop through an innovative cooperation model. It provides an academic exchange platform for rare targets, promotes standardized testing practices, strengthens scientific research collaboration, and benefits thousands of patients with rare mutations through a series of patient care initiatives, including patient education, testing assistance, and medication support programs.

Professor Zhang Li, Director of the Department of Medical Oncology at Sun Yat-sen University Cancer Center and co-founder of the Chinese Lung Cancer Rare Mutation Consortium, stated that lung cancer treatment is advancing rapidly. In recent years, precision medicine has developed swiftly, and next-generation sequencing (NGS) technology has been widely adopted in clinical practice. As a result, an increasing number of patients are being identified with rare genetic mutations, yet there remains a shortage of adequate therapeutic options and treatment information. It is precisely in response to this situation that the Chinese Lung Cancer Rare Mutation Consortium was established. The consortium aims to collaborate with colleagues across the field to share the latest therapeutic advances and case information on rare mutations, and to explore strategies for delivering better care to patients with these rare mutations.

According to the national cancer statistics released by the National Cancer Center in January 2019, there were 784,000 new cases of lung cancer in China, making it the most common cancer type in the country. Non-small cell lung cancer (NSCLC) is the most prevalent form of lung cancer, accounting for approximately 85% of all lung cancer cases. With the rapid development of precision medicine for lung cancer, an increasing number of targeted therapies have been approved for market launch, providing patients with more and better treatment options.

However, in contrast to targets such as EGFR, ALK, and ROS1, which have corresponding targeted therapies available, the current landscape for diagnosis and treatment of rare targets like c-Met, HER2, and RET remains unsatisfactory. Clinical guidelines do not yet recommend any first-line targeted therapeutic agents for these targets. Patients with rare mutations in these genes have become “rare patients” within the broader population of common cancers, urgently necessitating novel therapeutic options and greater societal attention.

For example, among rare genetic mutations, MET mutations are a typical type of rare mutation observed in lung cancer patients. In non-small cell lung cancer (NSCLC), patients with MET mutations have a poor prognosis and are insensitive to existing standard treatments; the overall survival (OS) with conventional chemotherapy is only six months.

In recent years, there has been considerable research on the rare target c-Met, but few breakthroughs have been achieved. However, with recent advances in basic and clinical research, as well as the emergence of new and exciting findings, the development of c-Met-targeted therapies has once again garnered significant attention within the industry.

Several clinical trials targeting MET mutations are currently underway in China. Among them, the “Study of Savolitinib in Treating Pulmonary Sarcomatoid Carcinoma (PSC) and Other Types of Non-Small Cell Lung Cancer (NSCLC) with MET Exon 14 Skipping Mutations” is an open-label, single-arm, multicenter Phase II clinical trial conducted in China. The results of this Phase II study have been published, showing an initial objective response rate exceeding 50%. These findings offer hope for survival to patients with lung cancer and pulmonary sarcoma driven by MET mutations.

The field of rare mutations requires greater attention, as well as increased integration and investment of resources. The establishment of the Chinese Collaborative Group on Rare Mutations in Lung Cancer facilitates the integration of diagnostic and therapeutic resources for rare mutations within the industry, mobilizing the enthusiasm of testing companies, pharmaceutical enterprises, social organizations, and medical experts. By concentrating the strengths of industry, academia, and research, this initiative aims to improve the standard of care for rare mutations and accelerate the development of novel therapeutics.

Meanwhile, it helps draw societal attention to patients with rare mutations, optimize the complete ecosystem loop for diagnosis and treatment, attract greater R&D investment, establish a robust collaborative network for the diagnosis and management of rare mutations, promote standardized testing and evidence-based treatment for these patients, and effectively safeguard their health rights and interests. Let us look forward to the imminent availability in China of therapies targeting MET mutations, thereby contributing to the Healthy China 2030 initiative.