Capmatinib Received FDA Approval for Metastatic NSCLC

Lung cancer, including both small and non-small cells, is the second most common cancer worldwide. In 2021, the prevalence was about 13% for all SCLC lung cancers, and 84% were NSCLC. According to the American Cancer Society reports, the 5-year survival rate for metastatic NSCLC is about 7%, this signifies that around 7% of people diagnosed with metastatic NSCLC are still alive after 5 years of their diagnosis. The World Health Organization (WHO) predicted that lung cancer is the ultimate cause of 1.59 million deaths globally every year, around 71% of which is caused by smoking. Approximately 500 000 deaths annually are signified by lung cancer in lifetime never-smokers. There was also a rise in the percentage of NSCLC in never-smokers, mainly in Asian countries. Both factors, such as smoking prevention and smoking cessation, can reduce a large fraction of lung cancers.

Non-small cell lung cancer (NSCLC) is the most common kind of lung cancer, especially metastatic NSCLC. There are four stages of NSCLC, wherein stage 4 is the most severe. The most common site for NSCLC to spread to is bone. The next common sites are lung, brain, adrenal gland, liver, and extrathoracic lymph in the percentage of 32.1, 28.4. 16.7, 13.4 and 9.5. There are varied treatment options for treating metastatic NSCLC, such as surgery, radiofrequency ablation, radiation therapy, chemotherapy, targeted drug therapy, and immunotherapy. Recently, targeted therapies are preferred over other therapies. These therapies offer a treatment opportunity wherein each gene is associated with a cell pathway that limits cancer growth. Targeted therapies block the pathways and slow down the growth and spread of cancer cells.

Please sneak into https://www.databridgemarketresearch.com/reports/global-non-small-cell-lung-cancer-market to know more about NSCLC market wherein our DBMR team has investigated the non-small cell lung cancer market and witnessed that North America dominates the non-small cell lung cancer market due to the prevalence of sophisticated healthcare infrastructure, increased research and development proficiencies by the pharmaceutical companies and rapid adoption of new and better healthcare technologies. Excessive tobacco consumption and active engagement in passive smoking are the two major factors responsible for non-small cell lung cancer.

• On 10 August 2022, the U.S. FDA recently approved Capmatinib for treating NSCLC patients. This applies to adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping.

Capmatinib is a small molecule kinase inhibitor that is targeted against c-Met. c-Met is a receptor tyrosine kinase that activates signaling cascades which are involved in organ regeneration and tissue repair in healthy humans. Capmatinib may cause photosensitivity reactions in patients following ultraviolet (UV) exposure. It has been researched and studied that patients with signs or symptoms of lung disease such as cough, dyspnea, and fever should have Capmatinib immediately and be permanently discontinued if the patient has no other possible causes of the lung-related symptoms identified.

This time the grant was regular by FDA. Although, back on 6 May 2020, Capmatinib was granted accelerated approval for the same indication based on the initial overall response rate (ORR) and duration of response (DoR), which was proved in the GEOMETRY mono-1 study. That was a multicenter, non-randomized, open-label, multi-cohort study. The shift from accelerated to regular approval was based on data from an additional 63 patients and an additional 22 months of follow-up time to evaluate DoR and verify clinical benefit.

The recent study analyzed 160 patients with metastatic NSCLC with a mutation leading to MET exon 14 skipping. They received 400 mg of Capmatinib orally twice daily with food until disease progression or unacceptable toxicity were examined. The primary and secondary end-points are mentioned in the following table:

The inclusion criteria of the participants involved the median age of patients to be 71 years, if they had stage IIIB or IV NSCLC, histologically or cytologically confirmed disease, and at least one measurable lesion. In addition, patients had to recover from their prior therapies and have an ECOG performance score of 0 or 1.

The patients were excluded from the study if they had prior treatment with crizotinib or any other cMET, human growth factor inhibiting agents, an EGFR mutation with sensitivity to targeted therapy, or an ALK-positive rearrangement. The patients were also excluded if they had clinically significant or uncontrolled heart disease, impairment of gastrointestinal function, or illness that may alter the absorption of the treatment.

Among the patients involved, 61% were female, 77% were White, 61% never smoked, 83% had adenocarcinoma, and 16% had CNS metastases. Among previously treated patients, 81% received one, 16% received two, and 3% received three prior lines of systemic treatment. Amongst previously treated patients, 86% received prior platinum-based chemotherapy.

The study results showed that among the 60 treatment-naïve patients, ORR was 68%, with a DoR of 16.6 months. Among 100 previously treated patients, ORR was 44%, with a DoR of 9.7 months. Besides this, some adverse events were also noticed in these patients. Patients' most common adverse reactions (≥20%) were nausea, musculoskeletal pain, oedema, fatigue, cough, vomiting, dyspnoea, and decreased appetite.

This study showed that the overall survival rate was higher in the treatment group than in the placebo group (previously treated patients). Patients who were previously treated with drugs such as crizotinib or any other cMET or human growth factor inhibiting agents faced half of the duration of response than the patients treated with Capmatinib. Thus, it is effective against metastatic NSCLC. The recommended dosage of Capmatinib is 400 mg orally twice daily with or without food.