Trial results for the Phase 2 study (NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of head or neck (SCCHN), or metastatic urothelial bladder cancer (mUBC) were posted on ClinicalTrials.gov on 2026-04-08. The trial reported an Overall Response Rate (ORR) of 15 participants in the metastatic NSCLC arm.
Background
Pembrolizumab (Keytruda) is an immunotherapy drug. This trial investigated its use in combination with IO102-IO103 for metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of head or neck (SCCHN), and metastatic urothelial bladder cancer (mUBC).
Trial design
The study (NCT05077709) was a Phase 2 multi-arm (basket) trial that investigated the safety and efficacy of IO102-IO103 in combination with pembrolizumab. It enrolled 63 participants across three arms: metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of head or neck (SCCHN), and metastatic urothelial bladder cancer (mUBC). The trial evaluated this combination as a first-line treatment.
Key results
The trial reported several key measurements across the three study arms:
- Overall Response Rate (ORR):
- Arm A (NSCLC): 15 participants
- Arm B (SCCHN): 8 participants
- Arm C (mUBC): 2 participants
- Progression Free Survival (PFS):
- Arm A (NSCLC): Median of 8.1 months (95% Confidence Interval)
- Arm B (SCCHN): Median of 7.0 months (95% Confidence Interval)
- Arm C (mUBC): Median of NA months (95% Confidence Interval)
- Duration of Response (DoR):
- Arm A (NSCLC): Median of 13.7 months (95% Confidence Interval)
- Arm B (SCCHN): Median of 12.5 months (95% Confidence Interval)
- Arm C (mUBC): Median of NA months (95% Confidence Interval)
- Complete Response Rate (CRR):
- Arm A (NSCLC): 1 participant
- Arm B (SCCHN): 0 participants
- Arm C (mUBC): 0 participants
What this means
The results from this Phase 2 trial provide initial insights into the activity of IO102-IO103 in combination with pembrolizumab as a first-line treatment for metastatic NSCLC, SCCHN, and mUBC. The observed Overall Response Rates and median Progression-Free Survival and Duration of Response values suggest potential clinical activity in these difficult-to-treat populations. These findings will inform further development and larger studies for this combination therapy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05077709, titled "IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC," were posted on 2026-04-08 on clinicaltrials.gov.