Rociletinib May Be Safe, Effective for the Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

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Rociletinib may be effective in advanced EGFR-mutated NSCLC with or without the T790M mutation.
Rociletinib may be effective in advanced EGFR-mutated NSCLC with or without the T790M mutation.

According to new findings presented at the 26th EORTC-NIC-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, rociletinib, a novel, oral, epidermal growth factor receptor (EGFR) inhibitor may be effective for the treatment of patients with EGFR-mutated non-small cell lung cancer (NSCLC).

In the international, phase 1/2 TIGER-X study, researchers enrolled patients with advanced EGFR-mutated NSCLC with or without the T790M mutation.1

EGFR-mutated NSCLC can be successfully treated with tyrosine kinase inhibitors (TKIs) like afatinib (Iressa) and erlotinib (Tarceva), but patients who have the T790M mutation develop resistance to this type of treatment.1-3 Rociletinib selectively targets both the EGFR-activating mutations and the T790M mutation.

“I define this as a third-generation TKI directed at mutant-EGFR. We now have been able to direct it against not only the activating mutations of EGFR, like first-generation EGFR inhibitors, but it also was designed to very potently inhibit a primary resistance mechanism called T790M, which is the cause of failure on Tarceva or Iressa in about 60% of patients,” said Patrick J. Mahaffy, MA, President and CEO of Clovis Oncology, the company that developed rociletinib.

RELATED: Ramucirumab Plus Pemetrexed and Platinum Chemotherapy Shows Clinical Activity in Advanced Nonsquamous NSCLC

The phase 1 portion of the study determined that rociletinib 625 mg twice daily was the best dose for the phase 2 portion. In the phase 2 part of the study, 56 patients with the T790M mutation received the 625 mg BID dose or the 500 mg BID step-down dose.

Participants had a median of three prior therapies. All patients had previously been treated with at least one prior EGFR TKI and 79% of patients had immediately progressed on TKI therapy prior to receiving rociletinib.1

Results showed that for the 27 evaluable patients with T790M-positive EGFR-mutated NSCLC, the objective response rate was 67%. The rate was similar among patients that received the 625 mg BID pivotal dose and the 500 mg BID reduced dose.

Furthermore, the disease control rate was 89% and the median progression-free survival was 10.4 months. In the 11 evaluable patients with T790M-positive EGFR-mutated NSCLC, researchers observed a 36% objective response rate and median progression-free survival of 7.5 months.

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