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FDA Approves ImmunityBio's Bladder Cancer Drug, Stock Rallies
FDA Approves ImmunityBio's Bladder Cancer Drug, Stock Rallies
Monday, the FDA approved ImmunityBio Inc's (NASDAQ:IBRX) Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
The drug is combined with the BCG vaccine, mainly used against tuberculosis and as a common treatment for some forms of bladder cancer.
Last year in May, the FDA issued a complete response letter to Anktiva plus BCG treatment, citing deficiencies related to the FDA's pre-license inspection of the company's third-party contract manufacturing organizations.
"The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.
The company says Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received FDA Breakthrough Therapy Designation and approval based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).
The CR rate for the 77 evaluable patients was 62%, with the upper end of the confidence interval being 73%.
The duration of the complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date.
The company adds that the prolonged duration of complete response results beyond 24 months with ANKTIVA and BCG exceeds the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the IBCG.
The duration of response is ongoing, so the final median duration of response has yet to be determined. 58% of patients with CR had a DOR ≥ 12 months, and 40% had a DOR ≥ 24 months.
Anktiva is expected to be available in the U.S. By mid-May 2024.
Price Action: IBRX shares are up 4.65% at $5.17 at the last check Tuesday.
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FDA Clears ImmunityBio's Bladder Cancer Drug At 2nd Attempt
After rejecting ImmunityBio's Anktiva last year, the FDA has cleared the drug as a treatment for bladder cancer, making it the company's first commercial-stage product.
Anktiva (nogapendekin alfa inbakicep, or N-803) can be used in combination with the BCG vaccine in non-muscle invasive bladder cancer (NMIBC) patients who had not responded to the BCG shot on its own, according to the FDA, which blocked the drug last year because of quality issues at a contract manufacturing plant used to make it.
The decision throws a lifeline to ImmunityBio, which refiled the drug last October and previously said it may struggle to remain in business if the FDA turned it down for a second time.
Anktiva is billed as a first-in-class IL-15 receptor agonist that activates natural killer (NK) and T-cell cells in the body to attack tumours, as well as memory T cells to extend the duration of that response. It can be used as maintenance therapy with BCG for up to 37 months in adults with NMIBC.
Borrowing from basketball terminology, ImmunityBio's chairman and chief scientific and medical officer, Patrick Soon-Shiong, said Anktiva's mechanism is a 'triangle offence' that "begins the evolution of immunotherapy beyond T cells alone."
There are few treatment options for patients who develop BCG-unresponsive bladder cancer, which raises the risk of the cancer spreading throughout the body. Around 40% of patients don't respond to BCG, and many go on to have their bladder removed to try to limit the disease.
In the QUILT 3.032 trial, Anktiva plus BCG achieved a complete response rate of 71%, a median duration of response of almost 27 months, and a 90% reduction in the need for bladder removal surgery.
Anktiva becomes another option for BCG-unresponsive BMIBC patients alongside MSD/Merck & Co's PD-1 inhibitor Keytruda (pembrolizumab) – approved by the FDA in 2020 – and Ferring Pharma's gene therapy Adstiladrin (nadofaragene firedenovec), which was cleared in 2022.
Further competition for Anktiva could also be on the way from CG Oncology, a recent Nasdaq debutante whose lead drug candidate, cretostimogene grenadenorepvec, is in phase 3 for BCG-unresponsive NMIBC.
ImmunityBio said its Anktiva should be launched in the US market next month, but hasn't yet disclosed its pricing plans.
It is also developing the drug for BCG-unresponsive NMIBC with high-grade papillary disease, BCG treatment-naïve NMIBC, several other oncology indications across solid tumours and blood cancers, and HIV.
Nogapendekin Alfa Inbakicept With BCG Approved For Type Of Bladder Cancer
The principal investigator of the study leading to approval said this new immunotherapy could be a "game changer" in bladder cancer.
FDA last night approved nogapendekin alfa inbakicept-pmln (NAI) (Anktiva; ImmunityBio) with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ. The immunotherapy, a first-in-class IL-15 receptor agonist, was approved for patients with or without papillary tumors, according to a statement issued by the FDA.1
Previously designated a breakthrough therapy, NAI has been dubbed a "superagonist" and was approved based on data from the phase 3 QUILT-3.032 trial (NCT0302285). The results showed 62% of the 77 patients treated with the combination had a complete response (CR); in addition, 58% of those with a CR had duration of response of at least 12 months, and 40% had a CR of at least 24 months.1
The most common adverse reactions were increased creatinine, dysuria, hematuria, frequent urination, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.
Patrick Soon-Shiong, MDImage credit: Wikipedia
"The FDA's approval of [NAI] marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," Patrick Soon-Shiong, MD, executive chairman and global chief scientific officer at ImmunityBio, said in a statement from the company. He explained the drug's mechanism as follows2:
"The 'triangle offense' of tumor cell killing by the body's immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin," Soon-Shiong explained.
In NMIBC, the cancer is located on the inside layer of the bladder wall, making treatment challenging. About 80% of all bladder cancer cases are this type, and the American Cancer Society estimates it will account for 16,000 deaths in the United States this year.
Thus, the long duration of response from NAI could be a "game changer" for patients with NMIBC, Karim Chamie, MD, associate professor of urology at UCLA and principal investigator for the QUILT-3.032 study, said in ImmunityBio's statement. "With this approval, [NAI] could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer."
One caveat is that most of the QUILT-3.032 study participants were White males; when the initial results were published in NEJM Evidence in December 2022, Chamie and coauthors noted that the poor responses for some of the female participants, coupled with their small sample, pushed the CR rate for women below the overall response rate.3
Last night's approval is a turnaround for ImmunityBio, which a year ago received a complete response letter from FDA over manufacturing issues uncovered at third-party facilities during an inspection.4
The combination is approved for maintenance therapy for up to 37 months. Company officials said NAI will be available in mid-May. Additional updates will be presented at the American Urological Association meeting on May 3, 2024.
References
1. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. April 22, 2024. Accessed April 23, 2024. Https://www.Fda.Gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer
2. ImmunityBio announces FDA approval of Anktiva, first-in-class IL-15 receptor agonist for BCG unresponsive non-muscle invasive bladder cancer. News release. ImmunityBio. April 22, 2024. Accessed April 23, 2024. Https://immunitybio.Com/immunitybio-announces-fda-approval-of-anktiva-first-in-class-il-15-receptor-agonist-for-bcg-unresponsive-non-muscle-invasive-bladder-cancer/
3. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle invasive bladder cancer. NEJM Evid. 2023;2(1). Doi: 10.1056/EVIDoa2200167
4. FDA decline to approve ImmunityBio's bladder cancer therapy, shares slump. Reuters. May 11, 2023. Accessed April 23, 2024. Https://www.Reuters.Com/business/healthcare-pharmaceuticals/immunitybio-slumps-fda-declines-approve-bladder-cancer-treatment-2023-05-11/
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