KEY TAKEAWAYS
- The phase II CONTACT-01 study evaluated the effectiveness of combining atezo and cabo vs traditional doc treatment in mNSCLC patients who had previously received αPD-(L)1 and chemo.
- The study’s primary endpoint was OS in the intent-to-treat (ITT) population, and secondary endpoints were PFS, ORR, DoR, and safety.
- The study reported no superiority of the atezo + cabo combination over docetaxel in terms of overall survival (OS) in the ITT population.
The phase III CONTACT-01 study compared atezolizumab (atezo) and cabozantinib (cabo) combo to traditional docetaxel (doc) treatment for metastatic NSCLC (mNSCLC) patients (pts) previously treated with αPD-(L)1 + chemo.
The study included pts with ECOG PS of 0-1 and confirmed mNSCLC progression after receiving αPD-(L)1 and chemo (concurrent or sequential, regardless of response to prior αPD-(L)1) and any known PD-L1 status (or available tissue for central testing). The pts were randomized to receive atezo 1200mg IV q3w + cabo 40mg PO qd or doc 75mg/m2 IV q3w, stratified by histology and sequence of prior NSCLC regimens. The primary endpoint was overall survival (OS) (ITT), with secondary endpoints being progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety.
In the trial, 366 points were assigned into two groups: atezo + cabo (n = 186) and doc (n = 180), 61% and 71% of pts had ECOG PS 1, and 74% and 76% had nsq histology, respectively. The median age of pts in both groups was 64 and 66 yrs. After a minimum follow-up of 10.9 months, there was no notable difference in overall survival (OS) between the two treatments – atezo + cabo and doc. The median duration of treatment was 4.2 mo (range, 0–20; atezo), 3.9 mo (0–21; cabo), and 2.1 mo (0–19; doc). All-cause adverse events (AEs) occurred in 98% (G3-4, 48%) of pts in the atezo + cabo arm and 94% (G3-4, 45%) in the doc arm. Due to these AEs, 17% and 14% of pts in the respective arms discontinued treatment. G3-4 AEs of special interest for atezo were seen in 15% and 4% (G5 in 1% and 0%) and for cabo in 14% and 2% (G5 in 2% and 2%), respectively. Grade 5 treatment-related AEs occurred in 2% of patients (4 pts); in the doc arm, it was observed in less than 1% (1 pt).
The CONTACT-01 analysis reported no superiority of atezo + cabo over doc in the ITT population. No new safety signals were observed.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04471428
Neal, J., Pavlakis, N., Kim, S., Goto, Y., Lim, S.M., Mountzios, G., Fountzilas, E., Mochalova, A., Christoph, D.C.C., Bearz, A., Quantin, X., Palmero, R., Antic, V., Chun, E., Edubilli, T.R., Lin, Y., Huseni, M., Scheffold, C., Vervaet, P., Newsom-Davis, T. Journal of Thoracic Oncology (2023).
