How effective is Mobosetinib/Mobosetinib, and are there any advantages?

In September 2021, Mobocertinib (Mobocertinib) received accelerated approval from the U.S. Food and Drug Administration (FDA) for patients with EGFR Adults with ex20ins-mutated locally advanced or metastatic non-small cell lung cancer who are receiving or have received platinum therapy as detected by a U.S. Food and Drug Administration-approved test.

The U.S. Food and Drug Administration's approval was based on a nonrandomized, open-label, multi-contract Phase 1/2 study (NCT02716116) that included 114 patients with these diseases from two cohorts: the dose escalation/expansion and expansion cohort (EXCLAIM) and the platinum-pretreated patient cohort (PPP). Mobosertinib showed consistent clinical benefit in both cohorts. An independent review committee found that mobosertinib had an overall response rate of 25-28%, a disease control rate of 76-78%, and a median progression-free survival of 7.3 months. In the EXCLAIM cohort, the median duration of response was not estimable, and overall survival was not reached at the study's reported data cutoff. In the PPP cohort, the median duration of response was 17.5 months and the median overall survival was 24.0 months. These findings are consistent with the long-lasting significant tumoricidal effects and even higher tumor suppressive effects of mobosetinib.

The safety profile of mobosetinib is that gastrointestinal and cutaneous adverse events are controllable, which is consistent with the known safety profile of EGFR-TKIs Diarrhea and rash were the most reported treatment-related adverse events in the trial, with diarrhea being the only grade 3+ treatment-related adverse event reported in more than 10% of patients. Overall, 42%-47% of patients experienced various grade 3+ treatment-related adverse events. Dose reduction was required in 22-25% of patients, and 10-17% discontinued moboxetinib treatment primarily due to diarrhea and nausea. Common low-grade adverse events that occurred in at least 30% of patients included paronychia, decreased appetite, dry skin, and vomiting.

Mobosetinib The original drug has been launched in China, but it is not included in the medical insurance. The price of the common specification 40mg*112 pills per box is about 40,000 yuan, which is very high. The Hong Kong clinical version specification 40mg*30 pills per box is priced at more than 7,000 yuan (the price may fluctuate due to exchange rates). Generic drugs of Mobotinib have also been put on the market for sale overseas. Its pharmaceutical ingredients are basically the same as those of the original drugs at home and abroad. For example, the production specifications of Laos Pharmaceutical Factory40mg*120 capsules per boxThe pricemay be At more than 4,000 RMB (the price may fluctuate due to the exchange rate), the price is relatively cheap.