Results from a Phase 3 study evaluating nivolumab with or without ipilimumab for recurrent Stage IV squamous cell lung cancer were posted on 2019-12-19. The Lung-MAP trial reported a median overall survival of 11 months for patients treated with nivolumab monotherapy.
Background
The Lung-MAP study investigated nivolumab, an immunotherapy, alone or in combination with ipilimumab, for patients with recurrent Stage IV squamous cell lung cancer. This trial aimed to determine if the combination therapy offered an advantage over nivolumab monotherapy in this patient population, particularly for those not eligible for biomarker-driven sub-studies.
Trial design
The Phase 3 Lung-MAP study (NCT02785952) enrolled 275 participants with recurrent Stage IV squamous cell lung cancer. The trial compared two treatment arms: nivolumab with ipilimumab versus nivolumab alone as second-line therapy. The study focused on patients not eligible for biomarker-driven sub-studies within the broader Lung-MAP program.
Key results
The trial reported the following key measurements:
- For Overall Survival (OS):
- Median OS in the nivolumab with ipilimumab arm was 10 months.
- Median OS in the nivolumab monotherapy arm was 11 months.
- For Investigator-assessed Progression-free Survival (IA-PFS):
- Median IA-PFS in the nivolumab with ipilimumab arm was 3.8 months.
- Median IA-PFS in the nivolumab monotherapy arm was 2.9 months.
- For Objective Response Rate (ORR):
- ORR in the nivolumab with ipilimumab arm was 18 percentage of participants.
- ORR in the nivolumab monotherapy arm was 17 percentage of participants.
- Regarding Grade 3 through 5 Adverse Events (related to study drugs):
- In the nivolumab with ipilimumab arm, reported counts were 1 participant, 1 participant, and 5 participants.
- In the nivolumab monotherapy arm, reported counts were 0 participants, 1 participant, and 2 participants.
What this means
The results from the Lung-MAP Phase 3 trial provide comparative data for nivolumab monotherapy versus nivolumab plus ipilimumab in recurrent Stage IV squamous cell lung cancer. While nivolumab monotherapy showed a slightly longer median overall survival of 11 months compared to 10 months for the combination, the combination arm demonstrated a slightly longer median progression-free survival of 3.8 months versus 2.9 months, and a marginally higher objective response rate (18% vs 17%). The reported Grade 3 through 5 adverse event counts also suggest a potentially higher incidence in the combination arm. These findings indicate that the addition of ipilimumab to nivolumab did not consistently improve efficacy across all measured outcomes and may be associated with more severe adverse events in this specific patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The primary completion results for the study NCT02785952, titled "Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers", were posted on 2019-12-19 on clinicaltrials.gov.