Newly Approved Tebentafusp Requires Up-Front Active Toxicity Management in Melanoma


Tebentafusp, the first FDA-approved treatment option for patients with unresectable or metastatic uveal melanoma, may cause mild cytokine release syndrome, an expert explains.

Tebentafusp-tebn (Kimmtrak) has an interesting side effect profile, according to Paul Nathan, PhD. Although patients receiving this agent initially required active toxicity management, none of the patients had to discontinue treatment because of adverse effects (AEs), as seen in findings from the phase 3 IMCgp100-202 trial (NCT03070392).1

The FDA recently approved tebentafusp-tebn as a treatment option for adult patients with unresectable or metastatic uveal melanoma whose disease harbors HLA-A*02:01.2

In an interview with Oncology Nursing News®, Nathan, a medical oncologist at Mount Vernon Cancer Centre, and lead IMCgp100-202 investigator, comments on tebentafusp’s safety profile and the toxicity management considerations for nurses.

“The drug is given intravenously once a week, and because it activates the T lymphocytes in the local environment, it can cause mild cytokine release syndrome,” noted Nathan. “Because you're getting cellular activation of immune cells, they release cytokines that have a whole-body effect, predominantly on blood pressure; [it] can make your blood pressure drop. It can also cause a lot of skin, itching, rash, and fever.”

“Those are the kind of things that are mainly associated with the drug,” he continued. “For the first 3 infusions, we mandate that patients stay overnight on the day of their infusion, so that they have their observations monitored and have fluid support if they need it. If they don't respond adequately to fluid support, they can have steroid hydrocortisone steroid treatments to reverse cytokine release syndrome—that wasn't required very often [in the trial].”

“Interestingly, with this drug, after 3 to 4 weeks of treatment, the side effect profile entirely changes. It’s like using 2 different drugs. Once patients get through the first 3 to 4 weeks, they no longer have to stay overnight. They come in, [receive their] infusion, and then go home.”

Nathan concluded that the biggest consideration for oncology nurses is remaining vigilant in detecting and managing cytokine release syndrome. The drug does not present any novel administration considerations, according to Nathan, and the most notable takeaway is its shift in toxicity following the third or fourth infusion.


Nathan P, Hassel JC, Rutkowski P, et al. Overall survival benefit with tebentafusp in metastatic uveal melanoma. N Engl J Med. 2021;385(13):1196-1206. doi:10.1056/NEJMoa2103485

  1. Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma. News release. Immunocore Holdings Limited; January 26, 2022. Accessed February 11, 2022.

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