ImmuniyBio is eyeing a move up the non-muscle invasive bladder cancer (NMIBC) treatment line for its immunotherapy Anktiva.
In a readout shared Monday, Anktiva given with Bacillus Calmette-Guérin (BCG), the current standard of care for high-risk NMBIC, bested BCG alone in patients with carcinoma in situ (CIS) with or without papillary tumors who were receiving BCG for the first time.
To date, Anktiva is only indicated once patients fail to respond or progress on BCG. The drug was initially approved in 2024 for BCG-unresponsive NMIBC CIS with or without papillary tumors, and in October it snagged a second approval for BCG-unresponsive patients with high-grade papillary-only tumors. The latest data in BCG-naïve patients positions Anktiva as a potential first-line option.
ImmunityBio kept a tight lid on the study details, only sharing that the efficacy win was enough to meet the primary endpoint of the 370-person study dubbed Cohort A of Quilt2.005. The drugmaker also shared that the most common treatment-emergent adverse events were consistent with those seen with BCG alone.
The rest of the data will be unveiled at an upcoming medical meeting, and in the meantime, ImmunityBio said its application to expand Anktiva’s indication to patients earlier in their disease course will be in the hands of the FDA by the end of the year.
“For nearly 40 years, BCG has been the gold standard for patients newly diagnosed with high-risk NMIBC, with limited innovation in the frontline setting,” Christopher Pieczonka, M.D., from U.S. Urology Partners and investigator on the QUILT-2.005 trial, said in a Nov. 9 statement. “By improving responses earlier in the disease course, this combination has the potential to help more patients remain disease-free longer [and] avoid additional treatments.”
Jeffries analysts estimate that the BCG-naïve setting could open Anktiva up to approximately 7,700 newly diagnosed U.S. patients annually, making for $2.2 billion in peak sales.
But the budding opportunity was not enough to stay investors. ImmunityBio’s stock fell by 20% Monday despite the positive readout. The good news, it seems, was overshadowed by lackluster quarterly results and the lack of detailed phase 3 data, which Jefferies analysts said could be interpreted as underwhelming.
In its Q3 financials published Monday, ImmunityBio reported a 4% revenue decline since Q2. The biotech generated $48.8 million, up 52% from the year before, but below analysts' expectations of $59.3 million and Q2 sales of $50.7 million.
The sales fumble is likely a result of an ongoing BCG shortage in combination with competition from J&J’s drug-device combination, Inlexzo, according to Jeffries analysts. Inlexzo, which was approved in 2025, has generated approximately $200 million in year-to-date sales compared to Anktiva’s $143.6 million.
“We see both as addressable,” Jefferies analysts said of the two barriers to Q3 performance.
The analysts view the BCG-naïve trial win as a “large value driver” for the biotech, especially as J&J’s Inlexzo is still weighed down in a BCG-naïve phase 3 with uncertain readout time.
As the only BCG-naïve CIS treatment with randomized data against BCG, Anktiva has a meaningful head start. And while plans haven’t been laid out just yet, there’s potential for the immunotherapy to break into the larger BCG-naïve papillary-only market, Jeffries said, which constitutes about 18,000 U.S. patients annually.