‘Groundbreaking’ injectable nivolumab reduces treatment burden for advanced kidney cancer
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Key takeaways:
- Subcutaneous nivolumab had noninferior pharmacokinetics and ORR compared with IV treatment.
- Results show markedly shorter administration time using subcutaneous nivolumab.
Subcutaneous nivolumab can reduce burdens on the health care system and patients with pretreated advanced or metastatic clear cell renal cell carcinoma compared with its IV formulation, according to data from a phase 3 CheckMate 67T trial.
The findings — presented at ASCO Genitourinary Cancers Symposium — showed subcutaneous nivolumab (Opdivo, Bristol Myers Squibb) had noninferior pharmacokinetics and overall response rate as IV nivolumab, and a median administration time more than 80% quicker.
“The burden of treatment felt by cancer patients is tremendous,” Saby George, MD, FACP, professor of oncology and director of network clinical trials at Roswell Park Comprehensive Cancer Center, said in a Roswell Park press release.
“If nivolumab can be given as a subcutaneous injection instead of an intravenous infusion, patients’ treatment experience will be significantly improved,” he added. “Instead of 1 hour in an infusion chair, they will get the injection done in 5 minutes.”
Background and methodology
Intravenous nivolumab has proven effective for treating various tumor types, but the limited availability of infusion chairs at treatment centers means that development of an effective subcutaneous version could ease treatment burden for patients and decrease the overall cost to the heath care system, according to study investigators.
“If nivolumab becomes available subcutaneously, we can administer it in the clinic instead of sending patients to infusion centers,” George said in the release.
The multicenter CheckMate 67T trial included 495 adults with metastatic clear cell renal cell carcinoma who had progressive disease during or after one or two previous systemic therapies and no prior immunotherapy treatments.
Researchers randomly assigned patients in a 1:1 ratio to receive subcutaneous nivolumab with recombinant human hyaluronidase PH20 (n = 248; median age, 64 years; 66% men) or IV nivolumab (n = 247; median age, 66 years; 69% men).
Hispanic patients accounted for at least 34% of study participants in both treatment arms.
Patients in the subcutaneous arm received treatment every 4 weeks, whereas the IV group received infusions every 2 weeks.
Results and next steps
Patients in the subcutaneous arm received a median 8.6 treatment doses (median administration time, 5 minutes), whereas those in the IV arm had a median of 17.7 doses (median administration time 30 minutes).
The subcutaneous nivolumab treatment arm had a higher ORR than those who received IV nivolumab (24.2% [95% CI, 19-30] vs. 18.2% [95% CI, 13.6-23.6]) and longer median PFS (7.23 months [95% CI, 5.13-7.49] vs. 5.65 months [95% CI, 5.29-7.39]).
Subcutaneous nivolumab also showed noninferior pharmacokinetic results, according to study investigators.
Subcutaneous nivolumab had a similar safety profile compared with IV nivolumab, with no new safety concerns, researchers said. However, study drug toxicity led to three deaths in the subcutaneous group and one in the IV arm.
Local site reactions occurred in 8.1% of patients in the subcutaneous cohort, but most resolved in an average of 3 days without treatment.
The FDA has already approved nivolumab for more than 20 “different indications across multiple malignancies,” George said during his presentation, and these findings could greatly benefit patients battling other forms of cancer.
“This is a groundbreaking achievement for patients and physicians, and will definitely make treatment easier for patients,” George said in the release.
References:
- George S, et al. Abstract LBA360. Presented at: ASCO Genitourinary Cancers Symposium; Jan. 25-27, 2024; San Francisco.
- Roswell Park. Subcutaneous nivolumab as effective as IV for renal cell carcinoma – with much faster treatment time (press release). Available at: https://www.roswellpark.org/newsroom/202401-subcutaneous-nivolumab-effective-iv-renal-cell-carcinoma-much-faster-treatment-time. Posted Jan. 27, 2024. Accessed Jan. 30, 2024.
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George S, et al. Abstract LBA360. Presented at: ASCO Genitourinary Cancers Symposium; Jan. 25-27, 2024; San Francisco.
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