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September 18, 2020 // -- BMS recently presented Opdivo (Odivo, common name: nivolumab) at the 2020 Virtual Conference of the European Society of Medical Oncology (ESMO) The latest results of the First-Line Treatment of Advanced or Metastatic Renal Cell Carcinoma (RCC) Phase III CheckMate-214 study (4-year data) in a joint low-dose Yervoy (ipilimumab, ipilimumma) phase III.
data show that more than half of patients treated with the OY combination across the study group survived four years later.
update represents the longest period of time for any immuno combination therapy in the first-line RCC.
data continue to demonstrate that the first-line treatment of Opdivo-Yervoy immuno combination therapy (OY combination) has long-term survival benefits and long-lasting remission compared to the targeted cancer drug Sutent (Sotan, generic name: sunitinib, Shonithini).
these continuing benefits were observed in the major patient groups (patients with mid-risk and high-risk risk prognosis factors) and intentional therapy (ITT, i.e. all randomized) patient groups.
CheckMate-214 is a randomized, open-label study that assessed the efficacy and safety of Opdivo (3mg/kg) and low-dose Yeervoy (1mg/kg) combination therapy (O3Y1) relative to standard first-line therapy Sutt (sunitinib) for first-line therapy in patients with advanced or metastasis RCC who had not previously been treated (primary treatment).
four-year data show that OY combination therapy continues to show better total lifetime (OS), objective mitigation rate (ORR), mitigation duration (DOR), and full remission rate (CR) compared to Sutent.
- A 48-month follow-up analysis in the IP patient group (n-847) showed that patients in the OY group showed significant improvement at the following endpoints compared to the Sutt group: (1) OS, the mid-OS in the OY group was 48.1 months. The Sutent group was 26.6 months (HR-0.65, 95% CI:0.54-0.78);
(2) ORR, the OY group is numerically higher (65% vs 50%).
(3) CR, the OY group is 10% and the Sutent group is 1%, which is consistent with the 42-month analysis.
(4) DOR, the OY group's mid-level DOR had not yet been reached, and the Sutent treatment group had 19.7 months.
- A 48-month follow-up analysis conducted in the ITT patient group (n-1096) showed that OY patients showed significant improvement at the following endpoints compared to the Sutt group: (1) OS, OY group mid-OS has not yet been reached, Sutent The group was 38.4 months (HR-0.69; 95% CI:0.59-0.81), the OY group had a four-year survival rate of 53.4% and the Sutent group 43.3%.
(2) ORR, the OY group is numerically higher (65% vs 52%).
(3) CR, the OY group is 11% and the Sutent group is 3%.
(4) DOR, the OY group's mid-level DOR had not yet been reached, and the Sutent treatment group had 23.7 months.
study, the safety of Opdivo-Yervoy immunological combination therapy was consistent with previous results, with no new safety signals or drug-related deaths during long-term follow-up. "The four-year results from the CheckMate-214 study continue to demonstrate the complementarity of dual immunotherapy and strengthen the depth and durability of opdivo and Yervoy combination therapy in patients," said Dr. Nick Botwood, vice president of oncology development at
Centennia.
, these data provide further evidence of the value of unique and complementary double checkpoint inhibition in advanced cancer treatment.
"Opdivo-Yervoy combination: The first immuno-oncology combination therapy for high-risk RCC in first-line therapy, Renal Cell Cancer (RCC), is the most common type of kidney cancer in adults, with more than 140,000 deaths worldwide each year.
incidence of RCC in men is about twice that of women, with the highest incidence in North America and Europe.
, patients diagnosed with metastatic or advanced kidney cancer have a five-year survival rate of only 12.1%.
Opdivo and Yervoy are both tumor immunotherapy, using the body's own immune system to fight tumors by targeting different regulatory elements in the immune system, where Opdivo targets blocking PD-1/PD-L1 paths and Yervoy targets blocking CTLA-4.
in the United States and the European Union, Opdivo-Yervoy immuno combination therapy was approved in April 2018 and January 2019, respectively, making it the first immuno-oncology combination therapy (I-O/I-O combination) for patients with high-risk RCC in first-line treatment.
Opdivo-Yervoy is the only dual immunotherapy approved by the FDA in the United States, with potential synergies for two different immune checkpoints (PD-1 and CTLA-4) and working in a complementary manner.
U.S. regulatory aspects, Opdivo-Yervoy combination therapy has been approved for six treatment adaptations for five types of cancer (melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer).
Origin: Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or MetastEdal Cell Cell Carcinoma.