ImmunityBio Announces QUILT Trial Results for BCG-Unresponsive Bladder Cancer and Advanced Metastatic Pancreatic Cancer at the 2022 American Society of Clinical Oncology Annual Meeting
ImmunityBio has released positive data from pivotal clinical trials for treatments in bladder cancer and advanced pancreatic cancer, presented at the ASCO Annual Meeting. In bladder cancer, 71% of patients achieved a complete response, with a median duration of 26.6 months, and a 91% rate of avoiding cystectomy. In pancreatic cancer, the Nant Vaccine doubled median overall survival to 6.2 months. The company is advancing combination immunotherapy strategies and aims to launch additional trials in earlier treatment settings.
- 71% complete response rate in bladder cancer patients, median duration of 26.6 months.
- 91% cystectomy avoidance rate for bladder cancer patients at 24 months.
- 100% overall survival for bladder cancer patients at 24 months.
- Nant Vaccine more than doubled median overall survival in advanced pancreatic cancer to 6.2 months.
- None.
- Data from trials underscore ImmunityBio’s vision of activating NK cells and T cells to advance care in difficult-to-treat cancers
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Bladder Cancer:
71% of BCG-unresponsive NMIBC patients who had failed on previous therapies showed a complete response with a median duration of 26.6 months; cystectomy avoidance rate of91% and100% bladder cancer overall survival at 24 months with0% immune-related serious adverse events (SAE) -
Advanced Metastatic Pancreatic Cancer: Nant Vaccine more than doubled median overall survival for patients versus historical overall survival with median overall survival in patients with third- to sixth-line pancreatic cancer at 6.2 months and treatment-related SAEs uncommon (
6% ) -
ImmunityBio is exhibiting at booth number 26135
“The theme at this year’s ASCO conference finally is about combination therapy and immunotherapy. We have been focused on this approach for the past decade and the trial results we presented at this year’s ASCO conference are validation that the approach of harnessing the patient’s immune system with a combination of NK and T-cell activation has clinical benefit,” said
The data demonstrate a potential new option for BCG-unresponsive non-muscle invasive bladder cancer patients who were treated with Bacillus Calmette-Guérin (BCG) plus N-803 (Anktiva™) and the doubling of historic overall survival rates in patients with advanced pancreatic cancer who were treated with the Nant Cancer Vaccine, N-803 (Anktiva, IL-15 cytokine fusion protein), and off-the-shelf PDL1-targeted high-affinity NK cell (PDL1 t-haNK) infusion.
“Collectively, bladder cancer and pancreatic cancer claim more than half a million lives globally each year, with many patients failing to respond to the current standards of care,” said
The study results presented at ASCO are summarized below:
QUILT 3032 BCG-unresponsive NMIBC CIS (Cohort A)
In an oral presentation on
Link to video presentation on ecancer.org:
Excellent safety and tolerability profile of N-803 + BCG for CIS
-
1% treatment-related SAEs -
0% immune-related AEs -
0% grade 4 and 5 AE
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71% Complete remission (CR) rate at anytime - 1 Months median durable complete remission
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96% Avoidance of bladder cancer progression at 24 months in responders -
91% Avoidance of cystectomy at 24 months in responders -
100% Bladder cancer-specific overall survival at 24 months - Favorable & familiar dosing schedule with activity localized to the bladder
QUILT 3.032 is an open-label, three cohort, multicenter Phase 2/3 study of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) and was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. The
QUILT 88 Pancreatic Cancer
The study results were presented on
- Nant Cancer Vaccine (NCV) more than doubled median OS versus historical OS (Manax ASCO GI 2019) of 3 months after >2L
-
Median overall survival in 3rd line subjects (n=34) was 6.2 months (
95% CI: 4.9, 9.8) -
Overall survival for ITT population (N=78) of 3rd, 4th and 5th line is 5.8 months (
95% CI: 4.0, 6.9) -
Treatment-related (TR) SAEs were uncommon (
6% ), no TR deaths were reported - All treatments were performed as outpatient
- Treatment ongoing for 25 patients
“For the first time, we are seeing clinical efficacy of immunotherapy in pancreatic cancer. Lung, Kidney, Head and Neck cancer, melanoma and many other cancers have been successfully treated with immunotherapy, but pancreatic cancer has been left behind in the revolution. Now, with ImmunityBio’s combination immunotherapy there is renewed hope for patients with this dreaded disease,” said
QUILT 88 is a Phase 2, randomized, three-cohort, open-label study evaluating the comparative efficacy and overall safety of standard-of-care chemotherapy versus low-dose chemotherapy in combination with PD-L1 t-haNK, N-803, and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The study is expected to enroll 328 subjects across all three cohorts (63 of 80 participants are currently enrolled in Cohort C, third-line or greater). The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).
Currently, four trial sites have been activated:
About
ImmunityBio’s clinical pipeline consists of 27 clinical trials—18 of which are in Phase 2 or 3 development—across 13 indications in liquid and solid tumors (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Anktiva™, ImmunityBio’s lead cytokine fusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the
The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: www.immunitybio.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding data from the clinical trials for certain of ImmunityBio’s product candidates, regulatory review process and timing thereof, potential implications to be drawn from the QUILT 3.032 and QUILT 88 studies, whether the described mechanism of action contributes to response rate and duration, potential commercialization of ImmunityBio’s product candidates, ImmunityBio’s product candidates as compared to existing treatment options, and clinical trial enrollment, advancements and data, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to
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