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STUDY DESIGN

TRIDENT-1: a multicenter, single-arm, open-label, multicohort clinical trial1

PHASE 1: dose escalation (RP2D)1*

First 14 days:
AUGTYRO 160 mg QD

Day 15 onward:
AUGTYRO 160 mg BID

PHASE 2: dose expansion and efficacy cohorts1†
(Pooled population, inclusive of RP2D)

TKI-naïve (n=71)

1 prior TKI and no prior chemotherapy (n=56)

PRIMARY EFFICACY ENDPOINT:

  • ORR as assessed by BICR per RECIST v1.11

KEY SECONDARY ENDPOINTS:

  • DOR, PFS1,2
  • icORR according to modified RECIST v1.1, assessed by BICR1

INCLUSION CRITERIA:

  • ROS1+ locally advanced or metastatic NSCLC1
  • ECOG performance status ≤11
  • Measurable disease per RECIST v.1.11
  • ≥8 months from first dose1

EXCLUSION CRITERIA:

  • Patients with symptomatic brain metastases1
  • Phase 1 was a dose escalation phase that determined the recommended Phase 2 dose (RP2D) at 160 mg once daily for 14 days and then 160 mg twice daily thereafter until disease progression or toxicity.1
  • Phase 2 efficacy population included patients who received at least 1 dose of AUGTYRO.1

BASELINE CHARACTERISTICS

ROS1+ NSCLC population in TRIDENT-11

Baseline Patient Characteristics TKI-Naïve Patients (n=71) TKI-Pretreated Patients (n=56)
Median age 57 (range: 28-80) 57 (range: 33-78)
Sex
Female 61% 68%
Male 39% 32%
Race
Asian 68% 48%
White 25% 45%
Hispanic or Latino 4.2% 1.8%
Black or African American 1.4% 1.8%
Never smoker 63% 64%
ECOG performance status of 1 66% 68%
Metastatic disease 94% 98%
CNS metastases by BICR 25% 43%
Adenocarcinoma 97% 95%

72% of TKI-naïve patients had no prior chemotherapy and/or immunotherapy treatment. All TKI-pretreated patients had received 1 prior TKI with no prior chemotherapy or immunotherapy.1‡

  • 28% of TKI-naïve patients had up to 1 prior platinum-based chemotherapy and/or immunotherapy.1

AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

BICR=blinded independent central review; CNS=central nervous system; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; icORR=intracranial objective response rate; NSCLC=non-small cell lung cancer; ORR=objective response rate; PFS=progression-free survival; RECIST=Response Evaluation Criteria In Solid Tumors; ROS1=proto-oncogene C-Ros1, receptor tyrosine kinase; RP2D=recommended Phase 2 dose; TKI=tyrosine kinase inhibitor.

References:

1. AUGTYRO [package insert]. Princeton, NJ. Bristol-Myers Squibb Company. 2. Cho BC, Camidge DR, Lin JJ, et al. Repotrectinib in patients with ROS1 fusion-positive non-small cell lung cancer: update from the pivotal phase 1/2 TRIDENT-1 trial. 2023; Presented at: 2023 World Conference on Lung Cancer; September 9-12, 2023; Singapore.