Advanced gastroenteropancreatic neuroendocrine tumors
Opdivo + Yervoy
Metastatic colorectal cancer
Imfinzi + TACE + bevacizumab
January 19, 2024
Novartis Reports Significant Reduction in Disease Progression or Death with Lutathera as First-Line Treatment for Advanced Gastroenteropancreatic Neuroendocrine Tumors
The results of the Phase III NETTER-2 trial demonstrate a substantial 72% reduction in the risk of disease progression or death with Lutathera, marking it as a promising first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In comparison to high-dose octreotide LAR alone, the combination of Lutathera and long-acting release (LAR) octreotide significantly extended the median progression-free survival (PFS) to 22.8 months, as revealed in patients with newly diagnosed grade 2 and 3 advanced GEP-NETs.
NETTER-2 stands out as the inaugural positive Phase III trial for a radioligand therapy (RLT) in the first-line setting, highlighting the potential of RLTs in earlier treatment lines. The efficacy endpoint analysis revealed a remarkable median PFS of 22.8 months (95% CI: 19.4 - not estimable) for the combination of Lutathera and octreotide LAR, in stark contrast to the 8.5 months observed with high-dose octreotide LAR alone.
The study did not reveal any novel or unforeseen safety findings, and the data align with the already established safety profile of Lutathera.
January 20, 2024
Revelation of Phase 3 Trial Results by BMS Underscores Opdivo plus Yervoy's Efficacy in Initial MSI-H/dMMR mCRC Treatment
Bristol Myers Squibb (BMS) has recently disclosed compelling findings from the Phase 3 CheckMate -8HW trial, demonstrating a significant and clinically meaningful improvement in progression-free survival (PFS) with the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) when compared to traditional chemotherapy in the initial treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). This marks a noteworthy milestone as the first dual immunotherapy regimen to surpass the efficacy of chemotherapy in this specific patient group.
The Opdivo and Yervoy combination exhibited a noteworthy enhancement in the primary endpoint of PFS, as assessed by Blinded Independent Central Review (BICR). The data showcased a remarkable 79% reduction in the risk of disease progression or death when compared to chemotherapy, focusing on centrally confirmed MSI-H/dMMR mCRC cases. The positive trend in PFS commenced around three months and demonstrated sustained effectiveness throughout the study. Median PFS had not been reached in the Opdivo plus Yervoy arm in contrast to 5.9 months in the chemotherapy arm. This favourable PFS outcome consistently extended across all predefined subgroups, including patients with KRAS or NRAS mutations and those with baseline liver, lung, or peritoneal metastases.
The safety profile of Opdivo plus Yervoy remained in alignment with previously reported data and adhered to established protocols, with no new safety signals identified.
January 19, 2024
Combination Therapy with Imfinzi, Transarterial Chemoembolization (TACE), and Bevacizumab Shows Significant Progression-Free Survival Benefit in Liver Cancer Eligible for Embolization.
Positive outcomes from the Phase III EMERALD-1 trial highlight the substantial improvement in clinical outcomes when AstraZeneca's Imfinzi (durvalumab) is combined with TACE and bevacizumab, compared to TACE alone, for patients with hepatocellular carcinoma (HCC) eligible for embolization. This marks a significant advancement, as EMERALD-1 becomes the first global Phase III trial demonstrating enhanced clinical results for systemic therapy in combination with TACE in this specific setting.
In EMERALD-1, the combination therapy involving Imfinzi plus TACE and bevacizumab demonstrated a 23% reduction in the risk of disease progression or death compared to TACE alone. Median PFS reached 15 months for patients treated with the Imfinzi combination, in contrast to 8.2 months with TACE.
EMERALD-1 Trial Results:
Median PFS (months):
Imfinzi plus TACE and bevacizumab: 15.0
Placebo plus TACE: 8.2
PFS rate at 12 months:
Imfinzi plus TACE and bevacizumab: 55.5
Placebo plus TACE: 39.8
Imfinzi plus TACE and bevacizumab: 22.0
Placebo plus TACE: 10.0
Objective response rate:
Imfinzi plus TACE and bevacizumab: 43.6
Placebo plus TACE: 29.6
The trial is set to continue as planned to evaluate the key secondary endpoint of overall survival (OS).
The safety profile of Imfinzi plus TACE and bevacizumab proved generally manageable and aligned with the known profile of each medicine.