KEY TAKEAWAYS
- The phase 2 trial aimed to assess patient and healthcare provider preference for atezo SC vs IV in NSCLC treatment.
- The primary endpoint focused on patient preference between atezo SC and IV administration.
- Patients consistently prefered SC over IV atezo, aligning with previous findings on formulation preference.
Atezolizumab (Atezo) subcutaneous (SC) is authorized for all atezo intravenous (IV) uses in the EU and UK. Findings from IMscin001 (NCT03735121) demonstrated consistent pharmacokinetics (PK), effectiveness, and safety between atezo SC and IV.
Federico Cappuzzo and the team spearheaded a study that aimed to assess patient and healthcare provider-reported preference between atezo SC and IV administration in non small cell lung cancer (NSCLC) treatment.
Patients with PD-L1-positive resected NSCLC (Stage II, IIIA, or selected IIIB; AJCC 8th ed), previously treated with chemotherapy and without recurrence, and untreated patients with PD-L1 high Stage IV NSCLC were screened. Eligible patients aged 18 and older with wild-type EGFR/ALK were randomized 1:1 to receive atezo SC (1875 mg) or IV (1200 mg) every 3 weeks.
After Cycle 3, patients switched to the alternative route of administration; after Cycle 6, patients expressed their preference and chose treatment for the continuation period. Patients with resected NSCLC continued treatment for up to 16 cycles. Patients with advanced NSCLC continued treatment until the investigator determined a loss of clinical benefit.
The primary endpoint was patient preference for atezo SC versus IV at Cycle 6. Key secondary endpoints included safety and patient-reported outcomes assessed by questionnaire.
Of 179 patients randomized, 117 had Stage IV NSCLC, and 62 had resected NSCLC. The completion rate for the patient preference questionnaire was 97.6% (n=123/126) and the majority of patients (70.7%) preferred atezo SC (n=87, 95% CI 61.9–78.6); 21.1% preferred IV (n=26); 8.1% had no preference (n=10).
The primary reasons cited for preferring atezo SC were its ability to reduce time spent in the clinic (64.4%, n=56/87) and its more comfortable administration route (46.0%, n=40/87). After Cycle 6, the majority of patients (79.4%) selected atezo SC for the continuation period.
Overall, 85.8% of patients were very satisfied or satisfied with atezo SC compared to 75.2% with IV. No new safety findings were detected, and there were no safety concerns associated with switching between treatments.
IMscin002 successfully achieved its primary objective, demonstrating patient preference for atezo SC over IV administration. Consistent with previous reports, the safety profile remained unchanged, reinforcing the preference for subcutaneous formulations.
The trial is sponsored by Hoffmann-La Roche.
Clinical Trial: https://clinicaltrials.gov/study/NCT05171777
Cappuzzo F, Zvirbule Z, Korbenfeld EP, et al. (2024) “Primary results from IMscin002: A study to evaluate patient (pt)- and healthcare professional (HCP)-reported preferences for atezolizumab (atezo) subcutaneous (SC) vs intravenous (IV) for the treatment of NSCLC.” Presented at ELCC 2024, Annals of Oncology (2024) 9 (suppl_3): 1-5. 10.1016/esmoop/esmoop102571 (244MO).