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Just now, the U.S. FDA approvedQuasi-ImmunityBio's Altor BioScience DevelopmentThe interleukin-15 (IL-15) superagonist Anktiva (nogapendekin alfa inbakicept), developed by ImmunityBio, Inc., is used in combination with Bacillus Calmette-Guérin (BCG) to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) accompanied by carcinoma in situ (CIS), with or without papillary tumors. Notably,Industry media Evaluate listed this therapy as one of the 10 therapies expected to be approved this year at the beginning of the year.Potential BlockbusterOne of the therapies.

Bladder cancer is a common type of cancer. Globally, approximately 430,000 people are diagnosed with this disease each year. In patients with non-muscle-invasive bladder cancer, the cancer cells are located within the bladder or have grown into the bladder cavity but have not yet spread to the muscle or other tissues.Patients with this type of cancer account for 75% to 85% of all bladder cancer patients.BCG is the standard therapy for treating such patients. While it is effective, the recurrence and progression rates among patients receiving BCG treatment remain high. In this situation, the recommended treatment is complete removal of the bladder (cystectomy) to prevent the spread of cancer.

This approval is mainly based on the results of the QUILT-3.032 trial. This is a single-arm, multi-center Phase 2/3 clinical trial involving 77 high-risk BCG-unresponsive NMIBC patients with CIS (with or without Ta/T1 papillary lesions) following transurethral resection. Patients received intravesical instillation.AnktivaInduction therapy and BCG treatment. Patients undergo cystoscopy and urine cytology every 3 months to evaluate tumor status, with follow-up lasting up to 2 years. Additionally, patients are required to have a biopsy within the first 6 months after starting treatment.The primary endpoints of the trial were complete response (CR) achieved at any time and the duration of complete response (DOR).CR is defined as negative findings in cystoscopy and urine cytology (with biopsy performed under specific circumstances).

The analysis shows,The CR rate for patients was 62% (95% CI: 51, 73). Additionally, 58% of patients achieving CR had a DOR ≥12 months, and 40% of patients achieving CR had a DOR ≥24 months.The most common adverse reactions (≥15%) include laboratory abnormalities, including increased creatinine, dysuria, hematuria, urinary frequency, urgency, urinary tract infection, hyperkalemia, musculoskeletal pain, chills, and fever.

▲Summary of Efficacy Results from the QUILT-3.032 Trial (Image Source: Reference [2])

Anktiva isAn IL-15 superagonist.IL-15 plays a crucial role in the immune system by influencing the development, maintenance, and function of natural killer (NK) cells and immune T cells.Anktiva consists of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein.It binds to the βγT cell receptor, directly and specifically stimulating CD8-positive T cells and NK cells while avoiding stimulation of regulatory T cells (Treg). Compared with natural, non-complex IL-15, Anktiva exhibits superior pharmacokinetic properties in patients and persists longer in lymphoid tissues, demonstrating enhanced anti-tumor activity. In 2019, Anktiva received Breakthrough Therapy Designation from the FDA for use in combination with BCG to treat patients with non-muscle-invasive bladder cancer in situ who previously responded poorly to BCG.

▲Mechanism of Action of Anktiva (Image Source: ImmunityBio, Inc. official website)

According to the ImmunityBio, Inc. official website, in addition to being used for the treatment of bladder cancer,The company is also evaluating Anktiva as a monotherapy or in combination therapy in multiple phase 2 trials for the treatment of lung cancer, colorectal cancer, ovarian cancer, acute myeloid leukemia (AML), glioblastoma, and HIV patients.

IL-15 is a target that has gained significant attention in the cancer field in recent years.In addition to Anktiva, Obsidian Therapeutics is also developing its engineered tumor-infiltrating lymphocyte (TIL) therapy, OBX-115, which expresses membrane-bound IL-15. This month, the announcedPhase 1 Clinical TrialThe results showed,OBX-115 Achieves a 50% Overall Response Rate in Treating Patients with Advanced or Metastatic Melanoma, with a 33% CR Rate; Median Progression-Free Survival Not Yet Reached, and the 6-Month Progression-Free Survival Rate is 67%.In December 2021, SOTIO Biotech announced a collaboration with MSD (Merck & Co.)Cooperation, to evaluate the efficacy and safety of its IL-15 superagonist SOT101 in combination with the重磅 PD-1 inhibitor Keytruda for the treatment of patients with advanced/refractory solid tumors.In addition to the cancer field, IL-15 is also an emerging target in the field of immune diseases.Novartis announced in January this year the acquisition of Calypso Biotech, obtaining the company's potential "best-in-class" anti-IL-15 antibody therapy for the treatment of various immune diseases.CALY-002CALY-002 is currently being evaluated in a Phase 1b clinical trial for its therapeutic effects in patients with celiac disease and eosinophilic esophagitis.

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References:

[1] FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. Retrieved April 22, 2024 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer

[2] Anktiva Prescribing Information. Retrieved April 22, 2024 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf

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