our poster entitled MOBA-CERT and have been platinum pretreated exon 20 insertion positive metastatic non-small cell lung cancer patients with or without prior anti-PD-L1 therapy. This slide shows my disclosures. Among patients with EGFR mutated non-small cell lung cancer, up to 12% harbor an EGFR exon 20 insertion mutation. Few effective therapeutic options exist for these patients. Anti-PD-L1 and anti-PD-L1 therapies, which are recommended in patients with non-small cell lung cancer who do not have activating mutations in EGFR, have limited efficacy in patients with EGFR exon 20 insertion positive non-small cell lung cancer. MOBA-CERT is an oral first-in-class irreversible EGFR tyrosine kinase inhibitor targeting EGFR exon 20 insertion positive non-small cell lung cancer. It holds a breakthrough therapy designation in the United States for patients with these mutations who previously progressed on platinum based chemotherapy and in patients with these mutations who received prior chemotherapy in China. On slide 4 is the objective of the study and the purpose of our analysis was to characterize the efficacy and safety of MOBA-CERT in platinum pretreated patients with EGFR exon 20 insertion positive non-small cell lung cancer in subgroups with and without prior anti-PD-L1 therapy. The current analysis included data from an open label phase 1-2 multicenter study. Patients received MOBA-CERT in it but 160 milligram dose given once daily orally and the primary endpoint was confirmed overall response rate by resist version 1.1 assessed by an independent review committee. Slide 6 we see the study design. The study was comprised of a part 1 dose escalation, part 2 expansion at the recommended phase 2 dose and part 3 extension in prior platinum treated patients. The platinum pretreated patient population in this analysis included 114 patients from all three parts of the phase 1 phase 2 trial. Slide 7 shows the baseline patient characteristics among the platinum pretreated patient population 43% of the patients that received prior immunotherapy either as monotherapy or in combination with chemotherapy and among those who received prior immunotherapy two-thirds had received two or more prior lines of systemic anti-cancer therapy and 58% have received immunotherapy as their most recent prior treatment. The confirmed overall response rate by the independent review committee in all platinum pretreated patients was 28%. The confirmed overall response rate per independent review committee was 25% in platinum pretreated patients with prior anti-PD-L1 therapy and 30% in platinum pretreated patients without prior PD-L1 therapy. Median durational response was 17.5 months in the subgroup with prior anti-PD-L1 therapy and 11 months in the subgroup without prior anti-PD-L1 therapy. Slide 9 shows the efficacy data from our study. We show the best change in baseline and target lesion volume by the independent review committee assessment with patients who received prior anti-PD-L1 therapy shown in red bars and those who did not in black bars. No marked differences were observed in these subgroups. Slide 10 shows the duration of treatment in confirmed responders by IRC assessment. Again patients who received prior anti-PD-L1 therapies are shown in the red bars and those who did not are shown in the black bars and again what you can see here is that no marked differences in terms of duration of treatment were observed between the two different subgroups. Slide 11 shows the progression-free survival. The median progression-free survival was similar in the two subgroups 7.4 months in platinum pretreated patients with prior anti-PD-L1 therapy and 7.3 months in platinum pretreated patients without anti-PD-L1 therapy. Slide 12 shows the overall survival which was 21.1 months in platinum pretreated patients with prior anti-PD-L1 therapy and 24 months in platinum pretreated patients without prior anti-PD-L1 therapy. The next slide shows the overall safety profile of mobacertinib and it was similar in the two subgroups. A higher proportion of patients with prior anti-PD-L1 therapy had grade 3 or higher treatment-related AEs versus those with no prior anti-PD-L1 therapy and it was 58% versus 39% respectively. Treatment-related adverse events at least 10% more frequent patients with prior anti-PD-L1 therapy included nausea, fatigue, and macular papular rash. Incidents of treatment-related diarrhea or pneumonitis or interstitial lung disease did not markedly differ between these two groups. In conclusion, mobacertinib demonstrated similar efficacy in patients with and without prior anti-PD-L1 therapies. Clinically meaningful benefits were consistently observed in both subgroups. The safety profile of mobacertinib was consistent with the EGFR-TKI class and manageable in both populations and these results suggest that mobacertinib is effective in platinum pretreated patients that have an EGFR exon 20 insertion mutation regardless of the sequence of treatment with prior anti-PD-L1 therapies. We'd like to acknowledge the patients, their families, and their caregivers and like to thank all the study investigators and their team members at each of the study sites.

MOBA-CERT

EGFR tyrosine kinase inhibitor

platinum pretreated patients

EGFR exon 20 insertion positive non-small cell lung cancer

anti-PD-L1 therapy