With ASCO21 in full force, the pharma companies are presenting multiple abstracts and highlights from several clinical trials. DelveInsight has curated abstracts that are of crucial importance in the domain. Have a look here.
Abstract # 4002: CheckMate 649: Bristol-Myers Squibb (BMS)/Ono Pharmaceuticals
On 5th June 2021, Bristol-Myers Squibb presented Phase III safety and efficacy results with Nivolumab plus Ipilimumab or Nivolumab plus Chemotherapy against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer.
The study is the largest randomized clinical trial, and known HER2-positive patients were excluded from the study. In this study, the patients were randomized to receive NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO + ipilimumab, or chemo.
After the minimum 12-month follow up, NIVO + chemo had a statistically significant OS benefit vs. chemo (HR 0.80 [99.3% CI 0.68–0.94; P = 0.0002]) in all randomized patients; PFS benefit was also seen (HR 0.77 [95% CI 0.68–0.87]). OS benefit was observed in multiple prespecified subgroups, consistent with the primary population. Grade 3–4 treatment-related adverse events (TRAEs) were reported in 59% (NIVO + chemo) and 44% (chemo) of pts.
The study had observed that NIVO plus chemo demonstrated superior OS vs. chemo alone, with clinically meaningful PFS benefit and improved, durable responses in previously untreated patients with advanced GC/GEJC/EAC. This study also showed an acceptable safety profile, and no new safety signals were identified.
Expert Views: They (KOL) expected that the data from this study would support the NIVO plus chemo as a new 1L standard treatment of patients with advanced non-HER2-positive GC/GEJC/EAC.
Abstract # 4003: CheckMate 577: Bristol-Myers Squibb (BMS)/Ono Pharmaceuticals
On 5th June 2021, Bristol-Myers Squibb has presented Phase III safety and efficacy results with adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal or Gastroesophageal Junction Cancer.
In the study, the Patients were randomized 2:1 to NIVO 240 mg or PBO Q2W for 16 weeks, followed by NIVO 480 mg or PBO Q4W. This study observed the distant recurrence was reported for 29% vs 39% and locoregional recurrence for 12% vs 17% of patients in the NIVO vs PBO groups, respectively. Median distant metastasis-free survival was 28.3 vs 17.6 months with NIVO vs PBO. Median progression-free survival 2 (PFS2; time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death, whichever is earlier) was not reached with NIVO vs 32.1 months with PBO (HR 0.77; 95% CI 0.60–0.99).
The study had shown that the adjuvant nivolumab demonstrated clinically meaningful efficacy in patients with resected EC/GEJC following neoadjuvant CRT compared to placebo. Also observed an acceptable safety profile and maintained QoL.
Expert Views: They (KOL) expected that the data from this study had supported the adjuvant nivolumab as a new standard of care for patients with resected EC/GEJC who received neoadjuvant CRT with residual pathologic disease.
Interestingly, the duo has presented clinically meaningful results from both of their trials. Let us discuss more how this is expected to transform the market and what factors are expected to further impact the growth of the Gastric or Gastroesophageal Junction Cancer Market.
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