Here are some of the studies presented at the European Society for Medical Oncology’s recent virtual congress that grabbed our attention.
Nivolumab plus cabozantinib could be a new first-line treatment option
People with advanced or metastatic kidney cancer who were treated with the novel combination of the PD-1 checkpoint inhibitor nivolumab (Opdivo) plus the cabozantinib (Cabometyx) lived longer and without disease progression compared to those who received standard treatment with sunitinib (Sutent). Participants in the combo arm of the 651-person CheckMate 9ER trial had 16.6 months progression-free survival while those given sunitinib had 8.3 months. The combo arm also had double the objective response rate, including complete response, compared to the sunitinib arm. More people in the combo arm did require a dose reduction or treatment discontinuation due to drug toxicity.
All three drugs have been used on their own as monotherapies for renal cell carcinoma (RCC) but the results of this phase III study suggest a new first-line therapy indication for the experimental combination. Other approved first-line combination therapies include pembrolizumab (Keytruda) plus axitinib (Inlyta), avelumab (Bavencio) plus axitinib, and nivolumab plus ipilimumab (Yervoy). Read more.
Ipilimumab/Nivolumab continues to show benefits after 4 years
More than half of patients with advanced RCC treated with nivolumab (Opdivo) plus ipilimumab (Yervoy) were alive after 4 years, according to updated results from the phase III CheckMate-214 trial. Across patient populations, including those of intermediate- and poor-risk, overall survival and drug response, including complete response, improved compared trial participants who were treated with sunitinib.
“Nivolumab plus ipilimumab was the first immunotherapy combination to demonstrate an overall survival advantage over sunitinib in intermediate- and poor-risk patients with advanced renal cell carcinoma,” said CheckMate -214 investigator Laurence Albiges, M.D., Ph.D., Head of Genitourinary Unit, Gustave Roussy Institute and a member of the KCA’s Medical Steering Committee. “Now, after four years, the durable efficacy seen in CheckMate -214 represents important progress towards the aim of changing survival expectations for these patients.” Read more.
Early phase trial of cabozantinib plus atezolizumab was promising for clear cell and non-clear cell RCC
The combination of cabozantinib (Cabometyx) plus atezolizumab (Tecentriq) had promising efficacy and safety in both clear cell and non-clear cell RCC patients, according to analyses of two cohorts from the phase 1b COSMIC-021 trial. Among clear cell RCC patients, positive PD-L1 status and higher levels of CD8+ T cells were associated with better overall response. Among the non-clear cell RCC cohort, this type of kidney cancer being less common than clear cell RCC and having fewer treatment options and worse outcomes, the combination therapy demonstrated response.
“Given the broad experience with cabozantinib as monotherapy for advanced kidney cancer, it’s very exciting to see the growing body of clinical evidence that demonstrates encouraging tolerability and clinical activity when combining cabozantinib with atezolizumab in this disease,” said Dr. Sumanta Pal, Clinical Professor at City of Hope in Duarte, California and the COSMIC-021 principal investigator. “We look forward to learning more about the potential of this combination regimen to improve outcomes for patients with advanced kidney cancer from the ongoing phase 3 CONTACT-03 trial.” Read more here. And here.
BIONIKK trial supports molecularly-driven frontline therapy selection
The BIONIKK (Phase 2 BIOmarker Driven Trial with Nivolumab and Ipilimumab or VEGFR TKI in Naïve Metastatic Kidney Cancer) trial showed that people with metastatic clear cell RCC (ccRCC) responded better or worse to one of three RCC treatments –nivolumab, a nivolumab/ipilimumab combination, or a TKI like sunitinib or pazopanib – based on a gene signature. The results support molecularly-driven frontline therapy for improved treatment responses in certain ccRCC patients.
“[The] BIONIKK trial provides evidence on the best candidates to receive TKI, nivolumab alone, or nivolumab/ipilimumab,” said lead study author Dr. Yann-Alexandre Vano, a medical oncologist at Hôpital Européen Georges-Pompidou in Paris, France. Read more.
Nivolumab plus ipilimumab is the most cost-effective treatment option in advanced RCC
Considering overall survival results, risks, and treatment costs for three treatment options for first-line advanced RCC, nivolumab plus ipilimumab offered increased survival with lower total costs compared to sunitinib or pembrolizumab plus axitinib. Cabozantinib was included among the comparators but overall survival data couldn’t be compared appropriately. Read more.