Pcn47 Real World Evidence of Daratumumab in Multiple Myeloma

Abstract

Objectives: KEYNOTE-426 demonstrated statistically and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) in ccmRCC subjects treated with P+A versus (vs) sunitinib. This NMA synthesized RCT evidence to indirectly compare the relative treatment effects of P+A vs other therapies. Methods: A systematic literature review identified RCTs of approved or investigational 1L treatments of mRCC. Fixed-effect Bayesian NMA was conducted to determine the relative efficacy of treatments; OS, PFS [hazard ratios (HRs)] and ORR (odds ratio [OR]) were presented with 95% credible intervals (CrIs). Results: 18 RCTs (total ITT population: 10,547) that evaluated 17 interventions were identified (10 evaluable for OS, 14 for PFS, 13 for ORR). P+A showed statistically significant OS benefit over 7 out of 9 interventions evaluated [ranging from interferon-alpha (IFN-a) (HR=0.43, 0.29-0.64) through bevacizumab (B) + IFN-a, B + temsirolimus (B+T), sunitinib, placebo, pazopanib to atezolizumab + bevacizumab (A+B) [HR=0.65, 0.43-0.99]. OS benefit favored P+A vs avelumab + axitinib (A+A) [HR=0.68, 0.43-1.09] and vs nivolumab + ipilimumab (N+I) [HR=0.75, 0.51-1.09], but was not statistically significant. P+A showed statistically significant PFS benefit over 11 out of 13 interventions evaluated [ranging from placebo (HR=0.26, 0.16-0.42) through sorafenib, IFN-a, axitinib, tivozanib, B+T, B+ IFN-a, pazopanib, atezolizumab, sunitinib to A+B (HR=0.77, 0.60-0.99)]; PFS benefit favored P+A over N+I [HR=0.81, 0.64-1.03] but was not statistically significant, and P+A showed no difference compared to A+A [HR=1.00, 0.76-1.32]. P+A showed statistically significant ORR benefit over 11 out of 12 interventions evaluated [ranging from placebo (OR=25.22, 7.93-110.97) , sorafenib, IFN-a, axitinib, B+T, B+ IFN-a, atezolizumab, A+B, sunitinib, pazopanib to N+I (OR=1.95, 1.35-2.82)]; results favored A+A over P+A [OR=0.86, 0.58-1.27], but were not statistically significant. Conclusions: These analyses suggest that P+A provides significant OS, PFS and ORR benefits when indirectly compared to majority of 1L ccmRCC treatments.

Choosing PD-1 Inhibitors in Oncology Setting, Left or Right?—Lessons From Value Assessment With ASCO-VF and ESMO-MCBS

“…To date, only a few reports have focused on application of two prominent tools-ASCO Value Framework (ASCO-VF), or the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), or both according to a contemporary cohort of randomized controlled trials (RCTs) to assess the value of anticancer drugs, suggesting that not all approved drugs were significantly associated with meaningful value and additionally exploring the extent of concordance or discordance between these two respective frameworks (Del Paggio et al, 2017;Foote et al, 2017;Vivot et al, 2017;Djatche et al, 2018). However, studies of value assessment were limited.…”