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1) The Phase 3 CASPIAN Trial met its primary endpoint of overall survival, reducing the risk of death by 27% in newly diagnosed patients with ES-SCLC after more than 2 years by combining durvalumab (Imfinzi) with what:*
a) durvalumab + tremelimumab
b) durvalumab + tremelimumab + etoposide cisplatin/carboplatin
d) durvalumab + placebo
The answer is C. Durvalumab treatment, in combination with platinum etoposide chemotherapy vs chemotherapy alone, in newly diagnosed patients with extensive-stage small cell lung cancer (ES-SCLC) showed that more than 10% had not progressed and remained on treatment at 2years vs 2.9% on chemotherapy alone.
2) At 18 months, of the patients who received durvalumab plus chemotherapy vs placebo in the CASPIAN Phase 3 Trial, 34% were alive vs 25%, respectively.*
TRUE. The addition of the durvalumab improved the median OS to 13.0 months versus 10.3 months with EP alone (HR 0.73; 95% CI 0.59-0.91; P=0.0047), with 34% (26·9–41·0) versus 25% (18·4–31·6) of patients alive at 18 months . As a result, in March 2020, the FDA approved durvalumab in combination with EP as first-line therapy for ES-SCLC.
3) What trial showed that adjuvant treatment with osimertinib (Tagrisso) reduced the risk of disease recurrence or death by 79% in patients with stage IB to IIIA EGFR-mutant NSCLC?*
The answer is A. Oral osimertinib (Tagrisso) (80 mg, once daily) was compared with placebo for a treatment duration of up to 3 years or until disease recurrence. At the time of the unblinding, randomized patients (n=682) had been followed up for at least 1 year. The DFS curves separated early on and showed an 83% reduced risk of disease recurrence for the osimertinib arm and 79% reduction in the risk of disease recurrence or death in patients at 2 years. Overall, at 2 years, 90% of patients were disease-free versus 44% in the placebo group, an incredible result.
4) Phase 3 CHECKMATE-227 found that patients with advanced NSCLC treated with nivolumab (Opdivo) plus ipilimumab (Yervoy) vs chemotherapy had a 21% reduced risk of death after a median follow up of about*
a) 13 month
b) 25 months
d) 51 months
The answer is C. With a median follow-up of 43.1 months, patients with PD-L1 ≥ 1% had a 21% reduced risk for death when treated with nivolumab plus ipilimumab when compared with chemotherapy (median 17.1 months vs 14.9 months; HR: 0.79; 95% CI: 0.67–0.93). Nivolumab monotherapy was somewhat lower, granting a 10% reduced risk of death (HR: 0.90; 95% CI: 0.77-1.06). Patients in the nivolumab monotherapy arm had a median OS of 15.7 months (HR: 0.9; 95% CI, 0.77-1.06). OS rates at 3 years were 33% for nivolumab plus ipilimumab, 29% for nivolumab monotherapy, and 22% for platinum doublet chemotherapy.
5) Data from phase 3 KEYNOTE-604 showed patients with ES-SCLC who received pembrolizumab (Keytruda) with chemotherapy improved overall survival vs chemotherapy and placebo.*
FALSE. Pembrolizumab/EP prolonged OS compared with the control combination (10.8 vs 9.7 months; HR: 0.80; 95% CI: 0.64-0.98; P = 0.0164), but it did not reach the superiority threshold, which was P ≤ 0.0128. The 12-month OS rate was 45.1% in the pembrolizumab arm compared with 39.6% in the placebo arm. Other trials looking at immunotherapy in this setting like the phase 3 IMpower 133 study, as well as the CASPIAN trial significantly improved OS compared with EP alone. However, both of these other trials provided stronger responses, raising the question of whether there may be a distinction in targeting PD-L1 as opposed to PD-1.