8-K: ImmunityBio's ANKTIVA Receives FDA Approval for Bladder Cancer Treatment

The FDA has approved ImmunityBio's ANKTIVA in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer, marking a significant advancement in immunotherapy.

Summary

• ImmunityBio's ANKTIVA, combined with Bacillus Calmette-Gurin (BCG), has been approved by the FDA for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
• ANKTIVA is a first-in-class IL-15 receptor agonist that activates the body's natural killer (NK) and killer T-cell immune system to attack tumor cells.
• The therapy stimulates memory T cells, leading to a long duration of complete response, with some patients exceeding 47 months and ongoing.
• In a clinical trial of 77 evaluable patients, the complete response rate was 62%, with the upper end of the confidence interval being 73%.
• 58% of patients with a complete response had a duration of response of at least 12 months, and 40% had a duration of response of at least 24 months.
• ANKTIVA is expected to be available in the U.S. by mid-May 2024.
• The company is considering a proposal to increase the number of shares authorized for issuance under the 2015 Equity Incentive Plan by up to an additional 19,900,000 shares.

Sentiment

Score: 9

Explanation: The document is highly positive due to the FDA approval of a novel therapy with strong clinical results and a clear path to commercialization. The potential for ANKTIVA to become a new standard of care and its application in other cancer types further boosts the positive sentiment.

Positives

• ANKTIVA represents a new treatment option for patients with BCG-unresponsive NMIBC, potentially reducing the need for radical surgeries.
• The therapy has demonstrated a high complete response rate and a long duration of response, exceeding benchmarks set by experts.
• ANKTIVA is well-tolerated, with adverse events consistent with that of BCG alone.
• The approval of ANKTIVA marks a significant milestone in the development of cancer vaccines and immunotherapies.
• The company is committed to helping patients access ANKTIVA through a patient assistance program.

Negatives

• The final median duration of response has yet to be determined as the duration of response is ongoing.
• There is no assurance that the proposal to increase the number of shares authorized for issuance will be approved by stockholders.

Risks

• There are risks associated with the commercial launch, execution, and timing of ANKTIVA.
• Regulatory submissions and reviews, including those outside the U.S., carry risks and uncertainties.
• The company's ability to continue its planned preclinical and clinical development programs is subject to risks.
• There are risks related to the company's ability to retain and hire key personnel.
• The company's ability to obtain additional financing to fund its operations is a risk.
• Potential product shortages or manufacturing disruptions could impact the availability and timing of the product.
• The company's ability to successfully commercialize its product candidates is subject to uncertainties.
• There are risks associated with scaling manufacturing and commercial supply operations.
• The company's ability to obtain, maintain, protect, and enforce patent protection is a risk.

Future Outlook

ImmunityBio plans to continue studying ANKTIVA in various cancer types and is exploring its potential in cancer vaccines and preventative vaccines. The company is also planning future studies for platinum-resistant ovarian cancer and acute myeloid leukemia.

Management Comments

• The FDAs approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors, said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.
• We are pleased that treatment with ANKTIVA now exceeds the clinically meaningful benchmarks established by the IBCG in 2016 for durable complete response, said Roger Buckley, with the IBCG.
• With this approval, ANKTIVA could represent a new standard of care for patients with NMIBC and has the potential to change the way we treat bladder cancer, said Karim Chamie, M.D., Associate Professor of Urology at UCLA and principal investigator for the QUILT 3.032 study.
• A new immunotherapy that builds upon our knowledge and experience with BCG as an immune stimulant is exciting to see, said Ashish Kamat, M.D., MBBS, an Endowed Professor of Urologic Oncology and Cancer Research at University of Texas MD Anderson Cancer Center.
• The addition of ANKTIVA to BCG gives NMIBC patients and their physicians a much-needed, new option to effectively treat the disease and offers an important non-surgical alternative to a cystectomy, said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network (BCAN).
• This appears to be a major advance in disease control in this patient population, especially when the low rate of serious adverse events is considered, stated Drs. Peter Black, Jonathan Suderman, and Marie-Pier St-Laurent from the University of British Columbia, Vancouver.
• One could make the argument that NAI [ANKTIVA] should now become the standard of care given its more rigorous clinical trial data, stated Drs. Peter Black, Jonathan Suderman, and Marie-Pier St-Laurent from the University of British Columbia, Vancouver.
• We believe that by orchestrating the innate and adaptive immune system and driving long-term complete remission, ANKTIVA has the potential to play a key role as the immunotherapy beyond checkpoints in multiple tumor types in the years to come, said Soon-Shiong.

Industry Context

This announcement is significant as it introduces a new class of immunotherapy beyond checkpoint inhibitors for bladder cancer, addressing a critical unmet need for patients who do not respond to BCG treatment. It also highlights the growing trend of using the body's immune system to fight cancer.

Comparison to Industry Standards

• The complete response rate of 62% with ANKTIVA exceeds the benchmark for clinically meaningful results established by experts at the International Bladder Cancer Group (IBCG).
• The duration of complete response exceeding 47 months is a significant improvement compared to traditional treatments for BCG-unresponsive NMIBC.
• The low rate of Grade 3/4 adverse events (0% to 3%) is comparable to or better than other immunotherapies and traditional treatments for bladder cancer.
• The results suggest that ANKTIVA could become a new standard of care for NMIBC, potentially replacing or supplementing existing treatments like cystectomy.
• The ongoing studies of ANKTIVA in other cancer types, such as non-small-cell lung cancer, colorectal cancer, and non-Hodgkins lymphoma, indicate a broader potential for this therapy compared to other bladder cancer treatments.

Stakeholder Impact

• Shareholders will likely react positively to the FDA approval and the potential for increased revenue.
• Patients with BCG-unresponsive NMIBC will have a new treatment option with the potential for long-term remission.
• Healthcare professionals will have a new tool to treat bladder cancer.
• Employees of ImmunityBio will be involved in the commercialization and further development of ANKTIVA.

Next Steps

• ANKTIVA is expected to be available in the U.S. by mid-May 2024.
• A conference call and webcast will be held on April 26, 2024, to discuss the FDA approval.
• Further updates on the ongoing analysis of QUILT 3.032 will be presented at the American Urological Associations annual conference on May 3, 2024.
• The company will seek stockholder approval for the proposed increase in shares authorized for issuance under the 2015 Equity Incentive Plan.
• The company will continue to study ANKTIVA in other cancer types and explore its potential in cancer vaccines.

Key Dates

Keywords

ANKTIVA, N-803, nogapendekin alfa inbakicept-pmln, bladder cancer, NMIBC, BCG, immunotherapy, FDA approval, IL-15 agonist, cancer vaccine