Abstract 136P
Background
We conducted a multicenter, open-label, phase 2 study to evaluate TIS + platinum-based chemo (cohort 1) or TIS + mono-chemo + beva (cohort 2) in EGFR-mutated nsq-NSCLC pts who progressed on EGFR TKI therapies. Our previous results showed that both cohorts met the primary endpoint (1-year PFS rate). Here, we report the updated analysis with extended follow-up.
Methods
EGFR-mutated, nsq-NSCLC pts who had failed prior EGFR-TKIs received induction therapy with TIS + carboplatin (CBP) + nab-paclitaxel (nab-P; cohort 1) or TIS + nab-P + beva (cohort 2) every 3 weeks for 4 cycles, followed by maintenance therapy with TIS + pemetrexed (cohort 1) or TIS + beva (cohort 2) for up to 31 cycles.
Results
A total of 123 pts were enrolled (cohort 1, n=69; cohort 2, n=54). As of Aug 2, 2024, minimum study follow-up time (from the last patient’s first dose to data cutoff) was 32.3 and 17.1 mo, respectively for cohort 1 and cohort 2. Median OS was 27.1 mo in cohort 1, and 2-year and 3-year OS rates were 53.5% and 38.2%, respectively. For cohort 2, median OS was not reached, with 2-year OS rate of 61.4%. Pts with EGFR exon 21 L858R mutation had significantly longer OS than those with exon 19 deletion in cohort 1, while no similar trend was observed in cohort 2. Median PFS was 7.6 and 10.3 mo, respectively (Table). After prolonged follow-up, toxicity was manageable, with no new safety signals observed in both cohorts. Table: 136P
| Cohort 1 TIS + CBP + nab-P | Cohort 2 TIS + nab-P+ beva | |
| Minimum study follow-up time∗, mo | 32.3 | 17.1 |
| Median OS, mo (95% CI) | 27.1 (17.5, 36.9) | NR (19.2, NE) |
| OS rate, % (95% CI) | ||
| 1-year | 75.2 (62.2, 84.2) | 78.8 (65.1, 87.7) |
| 2-year | 53.5 (40.1, 65.1) | 61.4 (45.3, 74.1) |
| 3-year | 38.2 (24.9, 51.5) | NR (NE, NE) |
| Median PFS, mo (95% CI) | 7.6 (5.8, 9.4) | 10.3 (6.4, 14.5) |
| 1-year PFS rate, % (90% CI) | 25.4 (16.4, 35.3) | 42.2 (30, 53.8) |
∗From the last patient’s first dose to data cutoff. NR, not reached; NE, not estimable.
Conclusions
TIS + platinum-based chemo (cohort 1) and TIS + mono-chemo + beva (cohort 2) demonstrated encouraging OS benefits and manageable toxicity for pts with EGFR-mutated nsq-NSCLC after EGFR TKI failure with extended follow-up. This study expands the treatment options for this patient population, allowing clinicians to tailor their choices based on individual patient circumstances.
Clinical trial identification
NCT04405674.
Legal entity responsible for the study
The authors.
Funding
BeiGene Ltd.
Disclosure
All authors have declared no conflicts of interest.
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