Nogapendekin Alfa Plus Checkpoint Inhibition Improves Survival in NSCLC

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Following its recent FDA approval in non-muscle-invasive bladder cancer, nogapendekin alfa has also shown overall survival benefits in addition to checkpoint inhibitor therapy in patients with non-small cell lung cancer.

3D illustration of lung cancer: © Crystal Light - stock.adobe.com

3D illustration of lung cancer: © Crystal Light - stock.adobe.com

Nogapendekin alfa inbakicept-pmln (N-803; Anktiva) demonstrated overall survival (OS) improvements in patients with second- and third-line non-small cell lung cancer (NSCLC) who progressed after checkpoint inhibitors and chemotherapy, according to data from the phase 2b QUILT-3.055 study (NCT03228667).1

ImmunityBio announced that it will meet with the FDA in June to discuss a registration path for nogapendekin alfa in NSCLC.

“The results we noted with the completion of the QUILT 3.055 basket trial across multiple tumor types in patients with late-stage cancers for whom standard of care plus checkpoints failed, validates our hypothesis that orchestration of [natural killer (NK)] cells with killer T cells and memory T cells could result in meaningful clinical improvements to current standards of care,” said Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer at ImmunityBio, in a press release.

“As with non-muscle-invasive bladder cancer, we believe that [nogapendekin alfa] enhanced the NK and T-cell activity critical for targeting and killing cancer cells which have entered the phase of tumor evasion and resistance,” added Soon-Shiong in the press release.

On April 22, 2024, the FDA approved nogapendekin alfa plus Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.2

About QUILT-3.055

The QUILT-3.055 study included 4 cohorts.3 Patients with NSCLC, small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, Merkel cell carcinoma, melanoma, renal cell carcinoma, gastric cancer, cervical cancer, hepatocellular carcinoma, or microsatellite instability-high or mismatch repair deficient solid tumor or colorectal cancer were included in cohort 1. These patients must have progressed following single-agent checkpoint inhibitor therapy and experienced a complete response (CR) or partial response (PR). They received nogapendekin alfa plus pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), avelumab (Bavencio), and durvalumab (Imfinzi).

In cohort 2, patients with NSCLC with high tumor PD-L1 expression and who relapsed on a PD-1 checkpoint inhibitor after experiencing a PR or CR were included. These patients received nogapendekin alfa plus pembrolizumab and nivolumab.

Cohort 3 included patients with NSCLC who initially experienced a PR or CR but then relapsed on maintenance PD-1 checkpoint inhibitor therapy after receiving a checkpoint inhibitor plus chemotherapy in the first line. They received nogapendekin alfa plus pembrolizumab and nivolumab.

Those in cohort 4 were actively receiving checkpoint inhibitor therapy and had disease progression after experiencing stable disease for at least 6 months. These patients received nogapendekin alfa plus pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.

Additionally, a fifth cohort of patients who experienced disease progression while receiving treatment in cohorts 1 through 4 received an additional PD-L1-targeted NK cell therapy.

The primary end point of the study is objective response rate, and secondary end points include disease-specific survival, OS, time to response, duration of response, incidence of adverse events, quality of life, and progression-free survival.

The study has an estimated primary completion date of May 2024.

REFERENCES:
1. ImmunityBio announces positive overall survival results of Anktiva combined with checkpoint inhibitors in non-small cell lung cancer; meeting scheduled with FDA to discuss registration path for ANKTIVA in lung cancer. News release. ImmunityBio. April 25, 2024. Accessed April 25, 2024. https://tinyurl.com/39hjwz6r
2. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. April 22, 2024. Accessed April 25, 2024. https://tinyurl.com/3bcnrzwy
3. QUILT-3.055: a study of combination immunotherapies in patients who have previously received treatment with immune checkpoint inhibitors. ClinicalTrials.gov. Updated August 29, 2023. Accessed April 25, 2024. https://www.clinicaltrials.gov/study/NCT03228667
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