TRACON Pharmaceuticals (NASDAQ: TCON) disclosed 'positive' top-line results from Phase 1 study of TRC105 and Opdivo in non-small cell lung cancer.
The San Diego-based TRACON put out a news release Wednesday in which it revealead that, in this Phase 1b trial, patients with refractory metastatic non-small cell lung cancer were enrolled regardless of baseline PD-L1 tumor expression.
Patients were treated with 8 mg/kg or 10 mg/kg of TRC105 weekly for four doses and then 15 mg/kg every two weeks, in combination with the approved dose of Opdivo of 240 mg every two weeks. Best response was assessed by immune RECIST 1.1.
The combination of TRC105 and Opdivo was well-tolerated without the development of dose limiting toxicity in six patients who were treated as part of dose escalation.
One of these six patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 10 months.
Two of the other five patients, one of whom who progressed following prior Opdivo treatment, remain on trial with stable disease.
According to CEO Charles Theuer, "We initiated this Phase 1 trial based on the potentiation of PD-1 checkpoint inhibition observed with TRC105 in pre-clinical models. We are pleased that TRC105 was well-tolerated with Opdivo, and with the early evidence of activity seen in the study. We expect to present data from the expansion cohorts in mid-2019."
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