Osimertinib

An open-label phase III trial (AURA 3 [NCT02151981]) studied osimertinib in patients with NSCLC and EGFR-sensitizing variants whose disease had progressed after first-line EGFR inhibitors. These patients had EGFR T790M resistance variants as determined by the cobas® EGFR Mutation Test.[28] The trial randomly assigned 419 patients (in a 2:1 ratio) to receive either osimertinib 80 mg by mouth every day or pemetrexed plus carboplatin or cisplatin IV every 3 weeks for up to six cycles; maintenance pemetrexed was allowed for the chemotherapy group. The primary end point was PFS.

An open-label phase III trial (AURA 3 [NCT02151981]) studied osimertinib in patients with NSCLC and EGFR-sensitizing variants whose disease had progressed after first-line EGFR inhibitors. These patients had EGFR T790M resistance variants as determined by the cobas® EGFR Mutation Test.[28] The trial randomly assigned 419 patients (in a 2:1 ratio) to receive either osimertinib 80 mg by mouth every day or pemetrexed plus carboplatin or cisplatin IV every 3 weeks for up to six cycles; maintenance pemetrexed was allowed for the chemotherapy group. The primary end point was PFS.

Osimertinib was superior to chemotherapy in prolonging median PFS (10.1 months vs. 4.4 months; HR, 0.30; 95% CI, 0.23–0.41; P < .001).

An open-label phase III trial (AURA 3 [NCT02151981]) studied osimertinib in patients with NSCLC and EGFR-sensitizing variants whose disease had progressed after first-line EGFR inhibitors. These patients had EGFR T790M resistance variants as determined by the cobas® EGFR Mutation Test.[28] The trial randomly assigned 419 patients (in a 2:1 ratio) to receive either osimertinib 80 mg by mouth every day or pemetrexed plus carboplatin or cisplatin IV every 3 weeks for up to six cycles; maintenance pemetrexed was allowed for the chemotherapy group. The primary end point was PFS.

The objective response was 71% with osimertinib versus 31% with platinum therapy (odds ratio for objective response, 5.39; 95% CI, 3.47–8.48; P < .001).

An open-label phase III trial (AURA 3 [NCT02151981]) studied osimertinib in patients with NSCLC and EGFR-sensitizing variants whose disease had progressed after first-line EGFR inhibitors. These patients had EGFR T790M resistance variants as determined by the cobas® EGFR Mutation Test.[28] The trial randomly assigned 419 patients (in a 2:1 ratio) to receive either osimertinib 80 mg by mouth every day or pemetrexed plus carboplatin or cisplatin IV every 3 weeks for up to six cycles; maintenance pemetrexed was allowed for the chemotherapy group. The primary end point was PFS.

Among 144 patients with central nervous system (CNS) metastases, median PFS duration was 8.5 months with osimertinib versus 4.2 months with platinum therapy (HR, 0.32; 95% CI, 0.21–0.49).

An open-label phase III trial (AURA 3 [NCT02151981]) studied osimertinib in patients with NSCLC and EGFR-sensitizing variants whose disease had progressed after first-line EGFR inhibitors. These patients had EGFR T790M resistance variants as determined by the cobas® EGFR Mutation Test.[28] The trial randomly assigned 419 patients (in a 2:1 ratio) to receive either osimertinib 80 mg by mouth every day or pemetrexed plus carboplatin or cisplatin IV every 3 weeks for up to six cycles; maintenance pemetrexed was allowed for the chemotherapy group. The primary end point was PFS.

Adverse events of grade 3 or greater occurred in 23% of osimertinib-treated patients versus 47% of platinum-treated patients.[28][Level of evidence B1]