Subcutaneous Opdivo confirmed comparable efficacy and security to IV Opdivo in beforehand handled superior or metastatic clear cell renal cell carcinoma.
Amongst sufferers with beforehand handled, superior or metastatic clear cell renal cell carcinoma (ccRCC), subcutaneous Opdivo (nivolumab and hyaluronidase-nvhy, Opdivo Qvantig) was equally efficient, protected and tolerable in comparison with intravenous (IV) Opdivo, scientific trial outcomes have proven.
Up to date outcomes from the part 3 CheckMate-67T scientific trial had been offered in the course of the 50th Annual Oncology Nursing Society Congress.
Outcomes confirmed that at a minimal follow-up of 15 months, the general response price (ORR) was 27% for subcutaneous Opdivo (248 sufferers) versus 21% for IV Opdivo (247 sufferers). ORR was a key secondary finish level powered for noninferiority. Notably, the research beforehand met its co-primary finish factors of time-averaged serum focus over the primary 28 days and minimal serum focus at regular state in the course of the main evaluation.
Extra knowledge from the up to date evaluation confirmed that the median progression-free survival (PFS) was 6.3 months with subcutaneous Opdivo versus 5.7 months with the IV formulation. The median time to response was 3.7 months in each arms. Six- and 12-month general survival (OS) charges had been 84% and 72%, respectively, for subcutaneous Opdivo, in contrast with 86% and 73%, respectively, for IV Opdivo.
“CheckMate-67T met its co-primary finish factors and key powered secondary finish level on the main evaluation, demonstrating pharmacokinetic and efficacy noninferiority of subcutaneous [Opdivo] to IV [Opdivo], ” lead research writer Daniel Adamczyk of Bristol Myers Squibb and colleagues wrote in a poster presentation of the info. “These knowledge additional help using subcutaneous [Opdivo] as a brand new possibility with decreased administration time to enhance affected person therapy expertise and well being care effectivity.”
In December 2024, the FDA accredited subcutaneous Opdivo to be used throughout accredited grownup stable tumor IV Opdivo indications as monotherapy, as monotherapy upkeep following completion of Opdivo plus Yervoy (ipilimumab) mixture remedy or together with chemotherapy or Cabometyx (cabozantinib). This regulatory resolution was primarily based on beforehand reported knowledge from CheckMate-67T.
CheckMate-67T Design
CheckMate-67T evaluated the security and efficacy of subcutaneous Opdivo in contrast with the usual IV formulation in sufferers with beforehand handled superior or metastatic ccRCC. Eligible sufferers had skilled illness development throughout or after a minimum of one prior systemic routine and had not beforehand obtained immuno-oncology remedy.
Enrolled sufferers had been randomly assigned to obtain both subcutaneous Opdivo at 1200 milligrams co-formulated with recombinant human hyaluronidase PH20 at 20,000 models each 4 weeks or IV Opdivo at 3 milligrams per kilogram each two weeks. Sufferers continued therapy till illness development, unacceptable toxicity, withdrawal of consent, completion of two years of therapy, or dying.
Past the co-primary pharmacokinetic finish factors and the important thing secondary finish level of ORR, DOR, illness management price, PFS and OS had been different secondary finish factors assessed by blinded impartial central assessment. Security assessments included the incidence of unwanted side effects, treatment-related unwanted side effects, injection-site reactions and therapy discontinuations as a result of unwanted side effects or treatment-related unwanted side effects.
The research enrolled sufferers throughout 75 websites in 17 international locations. Baseline traits and efficacy outcomes had been evaluated in all randomized sufferers, whereas security analyses included all sufferers who obtained a minimum of one dose of Opdivo. Baseline affected person demographics and illness traits had been comparable between the 2 arms.
Security Evaluation
Amongst sufferers handled with subcutaneous Opdivo (247 sufferers), any-grade unwanted side effects occurred in 93.1% of sufferers (grade 3, extreme, or 4, life-threatening, 40.1%) in contrast with 94.3% (grade 3/4, 46.5%) for these given the IV formulation (245 sufferers). Remedy-related unwanted side effects of any grade had been reported in 61.5% of sufferers within the subcutaneous arm, together with 11.7% who skilled grade 3/4. Any-grade treatment-related unwanted side effects occurred in 65.7% of sufferers within the IV arm, together with 17.1% who had grade 3/4.
Discontinuation as a result of any facet impact occurred in 12.6% of sufferers within the subcutaneous arm, together with 4.5% who discontinued therapy as a result of treatment-related unwanted side effects. These respective charges had been 13.9% and 5.3% within the IV arm.
Immune-modulating remedy was administered to 71.9% of sufferers who skilled an immune-mediated facet impact within the IV arm (64 sufferers), and 32.8% of those sufferers obtained corticosteroids equal to a minimum of 40 milligrams prednisone. These charges had been 70.8% and 49.2%, respectively within the IV arm (65 sufferers).
Choose any-grade treatment-related unwanted side effects within the subcutaneous Opdivo group included endocrine-related unwanted side effects at 12.6% (grade 3/4, 0.8%), gastrointestinal aide results at 6.1% (1.2%), hepatic occasions at 9.3% (1.2%), pulmonary occasions at 4.9% (1.6%), renal occasions at 1.2% (0.4%), skin-related occasions at 24.3% (1.2%) and hypersensitivity or infusion reactions at 2.4% (0.4%).
Within the IV group, any-grade treatment-related unwanted side effects included endocrine-related AEs at 18% (grade 3/4, 1.2%), gastrointestinal results in 6.9% (0.4%), hepatic results in 12.7% (1.2%), pulmonary results in 3.3% (0.8%), renal results in 2.4% (0.4%), skin-related results in 27.3% (1.2%), and hypersensitivity or infusion reactions in 2.7% (0.4%).
Notably, treatment-related native injection website reactions (LISRs) had been reported in 5% of sufferers within the subcutaneous arm versus 2% of sufferers within the IV arm. 5 sufferers within the subcutaneous group wanted intervention for LISRs, together with 4 who obtained topical corticosteroids. All LISRs reported within the subcutaneous arm had been grade 1, apart from a single grade 2 prevalence.
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