Phase Ib of repotrectinib plus osimertinib in patients with EGFR-mutated advanced non-small cell lung cancer
A drug combination shows promise in lung cancer patients who've stopped responding to standard treatment, offering a concrete option for an otherwise difficult-to-treat group.
The TOTEM Phase Ib study evaluated repotrectinib + osimertinib in 31 EGFR-mutated NSCLC patients resistant to prior lines of therapy, demonstrating an ORR of 22.2% and intracranial ORR of 33.3%, establishing the recommended Phase 2 dose. The results address the unmet need of osimertinib resistance, with efficacy comparable to emerging combinations in a particularly difficult-to-treat population.
What the study was
- Study design
- Phase Ib dose-escalation + dose-expansion trial (3+3 design)
- Population
- EGFR-mutated advanced NSCLC patients resistant to prior treatments including osimertinib
- Sample size
- 31
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Lung Cancer
Why it surfaced
Phase Ib clinical trial addressing a major unmet need (EGFR NSCLC resistance to osimertinib), reporting promising icORR of 33.3% and establishing RP2D. Small sample but prospective with Phase 2 expansion planned.
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