Anktiva Plus BCG: Telling Expected Immune Effects From Red Flags

With the US Food and Drug Administration's (FDA) October 14, 2026, expansion of nogapendekin alfa inbakicept-pmln (Anktiva) with Bacillus Calmette-Guérin (BCG) to adults with BCG-unresponsive, high-grade non-muscle invasive bladder cancer (NMIBC) with papillary-only tumors, more patients will receive an intravesical immunotherapy regimen that can last up to 37 months.

Alongside urinary symptoms, the regimen can cause systemic effects such as chills, fever, and musculoskeletal pain. Eppie Bass, APRN, a nurse practitioner in genitourinary oncology at Moffitt Cancer Center, told Oncology Nursing News that nurses play a central role in helping patients distinguish expected immune-related symptoms from those that warrant holding treatment.

What systemic adverse effects are reported with nogapendekin alfa inbakicept-pmln?

Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist designed to activate natural killer cells and CD8-positive T cells. In cohort A of the single-arm QUILT-3.032 trial (NCT03022825), which supported the original approval, the safety population included 88 patients. Systemic adverse reactions reported in at least 15% of patients included:

• Musculoskeletal pain: 17% (grade 3 or 4, 2.3%)
• Chills: 15% (no grade 3 or 4 events)
• Pyrexia: 15% (no grade 3 or 4 events)

The most common reactions overall were urinary, including dysuria and hematuria (32% each), urinary frequency (27%), micturition urgency (25%), and urinary tract infection (24%).2 In a pooled safety analysis of 180 patients from cohorts A and B, grade 3 treatment-related adverse events occurred in 3% of patients, with no grade 4 or 5 treatment-related events.

The papillary-only expansion was based on extrapolation of efficacy from CIS-containing disease rather than a new trial.

How should nurses describe expected immune-related symptoms to patients?

Bass said that patients should hear up front that some systemic symptoms are a sign that the treatment is engaging the immune system. "When you're using an immune-based drug, you can have some immune-based symptoms," she said.

She uses a familiar comparison to set expectations. "We often tell patients, think about like, you feel like you're coming down with something. You may still run to Walmart to do things, but you're just like, man, I kind of feel cruddy. I must be coming down with something. That's your body's immune system kicking in. That's normal. That's to be expected."

Framing mild fatigue and achiness as anticipated rather than alarming may help patients stay on a long maintenance schedule. Bass noted elsewhere in the interview that unmanaged adverse effects, more than missed surveillance visits, are what lead patients to stop treatment.

Which symptoms should prompt a call or a treatment hold?

Bass draws a clear line at symptoms that interfere with function or persist. If a patient reports chills overnight and joint pain severe enough that getting out of bed is difficult, she said, "that would be something that we're not expecting. That's kind of more of a high grade side effect. So we may hold the next treatment."

In that situation, the team may check a white blood cell count and assess whether a systemic event is occurring. Bass summarized the distinction patients are taught to recognize: "I feel cruddy, I feel kind of achy. That's your body's immune system kicking in versus I have such bad joint pain, I cannot move. I've had chills all night long. That's a reason to be more concerned."

Why does this distinction matter with BCG-based regimens?

Because nogapendekin alfa inbakicept-pmln is given with BCG, systemic symptoms can overlap with known BCG reactions. Prior Oncology Nursing News coverage of intravesical therapy noted that BCG commonly causes flu-like and urinary tract infection-like symptoms that tend to be cumulative, and that rare BCG sepsis can be life-threatening. That discussion also emphasized monitoring for signs of systemic absorption, including fever, chills, fatigue, nausea, and vomiting, and reviewing new symptoms before each instillation.

For triage, the key nursing task is separating short-lived, tolerable flu-like symptoms from high fever, rigors, or severe pain that may signal infection or a systemic reaction. Institutional protocols should define when nurses escalate to the provider and when a treatment is held.

How can teams reinforce the message?

At Moffitt, education is delivered both verbally and in writing. Advanced practice providers review expected adverse effects and reasons to call when treatment is ordered, and nurses provide a written handout in person or upload it to the patient portal after a virtual visit, Bass said in the interview.

Repeating the same 2-tier message, expected achiness vs symptoms that require a call, at each visit can help patients self-triage between weekly instillations.

What are the key takeaways for oncology nurses?

• Set expectations early: Mild fatigue and flu-like achiness can reflect immune activation and are anticipated with this regimen.
• Teach a clear threshold: Overnight chills or joint pain severe enough to limit mobility should prompt a call rather than watchful waiting.
• Know the systemic rates: Musculoskeletal pain (17%), chills (15%), and pyrexia (15%) were reported in cohort A.
• Escalate per protocol: Severe systemic symptoms may lead the team to hold the next instillation, check a white blood cell count, and evaluate for a systemic event.
• Keep BCG reactions in mind: Flu-like symptoms with BCG tend to be cumulative, and rare BCG sepsis can be life-threatening.
• Reinforce in writing: Pair verbal counseling with a handout or portal message patients can refer to between visits.
  

References

1. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. US Food and Drug Administration. October 14, 2026. Accessed October 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle
2. Anktiva. Prescribing information. ImmunityBio, Inc. Accessed October 15, 2026. https://www.drugs.com/pro/anktiva.html
3. ANKTIVA with BCG demonstrates 96% survival from bladder cancer at three years with median survival not yet reached in BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer. News release. ImmunityBio, Inc. December 16, 2025. Accessed October 15, 2026. https://www.businesswire.com/news/home/20251216185945/en
4. Chang SS, Chamie K, Kramolowsky E, et al. Prolonged progression-free survival, disease-free survival, and cystectomy avoidance with IL-15 receptor lymphocyte-stimulating agent NAI plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-unresponsive papillary-only nonmuscle-invasive bladder cancer. J Urol. 2026;215(1):44-56. doi:10.1097/JU.0000000000004782
5. Johnson K, Bologna S. Managing adverse events with intravesical therapies. Oncology Nursing News. October 8, 2026. Accessed October 15, 2026. https://www.oncnursingnews.com/view/managing-adverse-events-with-intravesical-therapies