February 10, 2017
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Osimertinib improves PFS in NSCLC compared with platinum therapy

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Osimertinib prolonged PFS in patients with T790M-positive advanced non–small cell lung cancer compared with platinum therapy, according to data from a phase 3 trial.

“Osimertinib [Tagrisso, AstraZeneca] is an oral, irreversible EGFR-TKI that is selective for both EGR and T790M resistance mutations with activity in the central nervous system,” Tony S. Mok, MD, of the department of oncology at Sir Y.K. Pao Centre for Cancer at the Chinese University of Hong Kong, and colleagues wrote. “In the phase 1 component of [the AURA clinical trial], a phase 1/phase 2 trial, the objective response rate for osimertinib in patients with T790M-positive non–small-cell lung cancer was 61%; the median duration of PFS was 9.6 months.”

Mok and colleagues performed an international, open-label, randomized trial on 419 patients with T790M-positive NSCLC. All patients had disease progression after first-line EGFR-TKI therapy, and were randomly assigned in a 2:1 ratio to be treated with either 80 mg of osimertinib daily or IV pemetrexed plus carboplatin or cisplatin.

Patients who received osimertinib had significantly longer PFS than those with platinum therapy and pemetrexed (10.1 months vs. 4.4 months; HR = 0.30; 95% CI, 0.23-0.41). Osimertinib also produced a better ORR (71%; 95% CI, 65-76) than platinum therapy plus pemetrexed (31%; 95% CI, 24-40; OR = 5.39; 95% CI, 3.47-8.48).

Patients with metastases to the central nervous system who were treated with osimertinib had longer median PFS than those receiving platinum therapy plus pemetrexed (8.5 months vs. 4.2 months; HR = 0.32; 95% CI, 0.21-0.49). The group randomized to osimertinib also had a lower proportion of patients who experienced grade 3 or higher adverse events than those undergoing platinum therapy plus pemetrexed (23% vs. 47%).

The most common adverse events in the osimertinib group were diarrhea (n = 113; 41%), rash (n = 94; 34%), dry skin (n = 65; 23%) and paronychia (n = 61; 22%).

“The safety profile of osimertinib was consistent with that reported previously and differed from that in the platinum-pemetrexed group,” the researchers wrote. “The safety profile in the platinum-pemetrexed group was consistent with that observed in the cisplatin-pemetrexed group in the IMPRESS trial. Overall, adverse events tended to be more severe in the platinum-pemetrexed group, despite the long treatment duration with osimertinib. In conclusion, osimertinib was more effective than combination platinum-based chemotherapy in patients with T790M-positive NSCLC after disease progression with first-line EGFR-TKI therapy.” – by Andy Polhamus

Disclosure: Mok reports no relevant financial disclosures. The study was supported by AstraZeneca.