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Selumetinib regimen fails to prolong PFS in NSCLC

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The addition of selumetinib to docetaxel chemotherapy as second-line treatment failed to extend PFS in patients with KRAS mutation–positive, locally advanced or metastatic non–small cell lung cancer, the agent’s manufacturer announced today.

The randomized phase 3 SELECT-1 trial included 510 patients with NSCLC.

All patients received 75mg/m² docetaxel via IV on day 1 of each 21-day cycle. Researchers randomly assigned study participants to also receive 75 mg oral selumetinib (AstraZeneca) — an oral, highly selective MEK 1/2 inhibitor — twice daily or placebo.

The study failed to meet its primary endpoint of PFS. The combination also had no significant effect on OS.

“A randomized phase 2 trial showed promising activity of selumetinib in combination with docetaxel in patients with KRAS mutation–positive lung cancer,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release. “It is disappointing for patients that these results have not been confirmed in phase 3.”

The adverse event profiles for selumetinib and docetaxel were consistent with those seen in previous trials, according to the press release.

Complete data from SELECT-1 will be submitted for presentation at a future medical meeting.

“We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments,” Bohen said.

The FDA previously granted selumetinib orphan drug designation for treatment of patients with differentiated thyroid cancer. The agent also is being studied as a possible treatment for patients with neurofibromatosis type 1, a genetic disorder that causes tumors to grow along nerve tissue.

The release of the SELECT-1 results comes 4 days after Bristol-Myers Squibb announced monotherapy with nivolumab (Opdivo), its PD-1 immune checkpoint inhibitor, failed to extend PFS in treatment-naive patients with advanced, PD-L1–positive NSCLC.