First-line camrelizumab-chemo combo boosts OS in advanced squamous NSCLC
Treatment comprising camrelizumab, carboplatin, and paclitaxel in the first-line setting improved overall survival (OS) in patients with advanced squamous non-small-cell lung cancer (NSCLC), according to updated results of the phase III CameL-sq trial from China.
“Addition of camrelizumab to chemotherapy continued to demonstrate survival benefits after prolonged follow-up,” said Dr Caicun Zhou from the Shanghai Pulmonary Hospital, Tongji University, Shanghai, China, at ELCC 2022.
Participants were 390 patients with stage IIIB–IV squamous NSCLC, ECOG performance status (PS) 0–1, and who had not received prior systemic treatment. They were randomized 1:1 to receive carboplatin (AUC 5) + paclitaxel (175 mg/m2) in addition to either camrelizumab (200 mg; n=193; median age 64 years, 92.7 percent male) or placebo (n=196; median age 62 years, 91.8 percent male) on day 1 Q3W for 4–6 cycles.
Those who received camrelizumab or placebo continued this treatment at the same doses and dosing schedule until disease progression or unacceptable toxicity, with patients in the placebo group subject to conditional cross over to receive camrelizumab. Camrelizumab could be given for ≤2 years. Patients in the camrelizumab and placebo groups received a median 12 and seven cycles of those respective treatments, plus a median five cycles each of carboplatin and paclitaxel.
Patients in the camrelizumab and placebo groups were followed up for a median 23.7 and 15.2 months, respectively. Patients were primarily of ECOG PS 1 and 72 percent had stage IV disease. Thirteen and 11.2 percent of patients in the camrelizumab and placebo groups, respectively, had liver or brain metastases. Eight-four and 80 percent, respectively, had a smoking history comprising ≥400 cigarette-years. PD-L1 tumour proportion score was <1 percent in 47.2 and 49.5 percent, respectively, and ≥1 percent in 49.2 and 47.4 percent, respectively.
The present updated analysis showed an improvement in OS with camrelizumab + chemotherapy compared with placebo + chemotherapy (median 27.4 vs 15.5 months; hazard ratio [HR], 0.57, 95 percent confidence interval [CI], 0.44–0.74; p<0.0001). [ELCC 2022, abstract 3M0]
The probability of OS with camrelizumab + chemotherapy vs placebo + chemotherapy was 75.0 percent vs 62.0 percent at 12 months, 53.4 percent vs 35.0 percent at 24 months, and 42.8 percent vs 23.7 percent at 36 months.
The improvement in OS with camrelizumab + chemotherapy persisted after adjusting for the 106 patients (55.8 percent) in the placebo + chemotherapy group who crossed over to receive second-line camrelizumab (median 27.4 vs 12.4 months; HR, 0.41, 95 percent CI, 0.30–0.56; p<0.0001).
Grade 3–4 treatment-emergent adverse events (TEAEs) were documented in 81.9 and 75.0 percent of camrelizumab + chemotherapy and placebo + chemotherapy recipients, respectively. TEAEs led to death in 10.4 and 13.8 percent, respectively. Grade 3–4 treatment-related AEs occurred in 74.1 and 71.4 percent, respectively, with TRAEs leading to death in 3.1 and 1.5 percent, respectively. Immune-related AEs occurred in 77.2 and 20.4 percent, respectively.
There were no new safety signals observed in this trial, commented Zhou.
These results follow on the previous progression-free survival benefit noted with camrelizumab + chemotherapy vs placebo + chemotherapy (median 8.5 vs 4.9 months; HR, 0.37, 95 percent CI, 0.29–0.47; p<0.0001). [J Thorac Oncol 2022;17:544-557]
“These data further support camrelizumab + carboplatin and paclitaxel as a standard first-line treatment option for advanced squamous NSCLC,” said Zhou.