Shenzhen Forward Pharma Is Developing A New Targeted Therapy For Treating EGFR-mutated Lung Cancer

FWD1509, developed by Forward Pharma as a 4th generation EGFR targeting drug, is designed to treat EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC). The EGFR exon 20 insertion mutation accounts for about 10% of the EGFR mutation population, and there is currently no targeted therapy available for it in clinical practice, making the clinical demand for FWD1509 huge.

Spectrum Pharmaceuticals Inc.'s (SPPI) Poziotinib is a broad-spectrum EGFR inhibitor used to treat non-small cell lung cancer with EGFR and Her2 exon 20 insertion mutations. Recently, Spectrum released clinical data from the first line of treatment for NSCLC using Poziotinib. The study did not meet its primary endpoint of overall response rate, with an overall response rate (ORR) of only 14% among 115 patients.

In contrast, Forward Pharma 's research data showed that FWD1509 demonstrated significantly better activity, selectivity, and safety than AZD9291 and Poziotinib in both in vitro cell models and primary tumor models (PDX) of lung cancer patients with EGFR exon 20 insertion mutations. Additionally, in the treatment of brain metastasis in lung cancer, FWD1509's ability to penetrate the blood-brain barrier was significantly better than AZD9291. In the future, FWD1509 could be developed to treat patients with common EGFR mutations (L858R, 19Del), drug-resistant mutations (T790M), and brain metastases in exon 20 insertion mutated lung cancer, which will target a larger clinical market.

Overall, FWD1509 has a strong inhibitory effect (nM level) on various types of EGFR mutations, including 19-del, L858R, T790M, L861Q, S768I, and exon 20 insertion mutations. It does not have a significant inhibitory effect on wild-type EGFR, with a selectivity window greater than 500 times. Additionally, FWD1509 has significantly better ability to penetrate the blood-brain barrier than AZD9291. Therefore, this drug will effectively control clinical progression and metastasis of lung cancer, significantly prolong patients' survival and improve quality of life, serving the vast majority of disease patients and meeting enormous clinical demand.