Nogapendekin Alfa Combo Earns Approval in Saudi Arabia for Metastatic NSCLC

Saudi Arabia’s Saudi Food and Drug Authority (SFDA) has given accelerated approval to nogapendekin alfa inbakicept-pmln (Anktiva) plus immune checkpoint inhibitors for adults with metastatic non–small cell lung cancer (NSCLC) following progression on standard-of-care treatment, according to a news release from the developer, ImmunityBio, Inc.¹

The SFDA based its approval on data from the phase 3 QUILT-2.023 trial (NCT03520686) and the phase 2b QUILT-3.055 trial (NCT03228667). Previously announced data from QUILT-2.023 showed that nogapendekin alfa plus checkpoint inhibitors produced a statistically significant and sustained improvement in absolute lymphocyte counts (ALCs) vs checkpoint inhibitors alone among those with frontline NSCLC (P = .0065).² Additionally, 77% of patients with second- or later-line NSCLC in the QUILT-3.055 trial who received nogapendekin alfa plus immune checkpoint inhibitors had restored or maintained an ALC of 1.0 x 10³ cells/µL or higher.

Further data showed a median overall survival (OS) of 16.2 months among patients who responded to treatment with nogapendekin alfa vs 11.8 months among those who did not respond (HR, 0.52; P = .0369). Among those with an ALC of at least 1.2 x 10³ cells/µL, the median OS was 21.1 months regardless of PD-L1 expression status, which exceeded historical values of 7 to 9 months reported with standard-of-care chemotherapy (P = .0369).

“This approval represents a significant step forward for [patients with] lung cancer in the Kingdom of Saudi Arabia and a meaningful milestone that we hope will pave the way toward additional approvals across a region where lung cancer claims far too many lives each year. This combination of [nogapendekin alfa] plus a checkpoint inhibitor serves as a foundational backbone to immunotherapy 2.0, enabling activation of the complex immune system through subcutaneous outpatient therapy,” Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer at ImmunityBio, stated in the news release.¹ “We are pleased that the [SFDA] recognized the significance of [nogapendekin alfa] in restoring and maintaining immune competence and achieving prolonged survival in patients with lung cancer who have exhausted all standards of care.”

According to the news release, investigators are conducting the confirmatory phase 3 ResQ201A trial (NCT06745908) evaluating nogapendekin alfa–based therapy among patients who progressed on prior chemoradiotherapy and checkpoint inhibitors. Specifically, patients will be assigned to receive nogapendekin alfa at 1.2 mg subcutaneously plus tislelizumab-jsgr (Tevimbra) at 200 mg intravenously and docetaxel at 75 mg/m² intravenously or docetaxel monotherapy.³ The trial’s primary end point will be OS.

Patients 18 years and older with pathologically confirmed stage IV NSCLC, acquired resistance to an immune checkpoint inhibitor, an ECOG performance status of 0 to 2, and measurable lesions based on RECIST v1.1 criteria are eligible for enrollment on the ResQ201A trial. Those with actionable genomic alterations must have at least 1 of the following alterations to enroll: EGFR, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, or KRAS.

Those with systemic autoimmune disease currently requiring treatment, such as rheumatoid arthritis, Addison disease, or autoimmune disease related to lymphoma; ALK-altered disease; a history of organ transplant requiring immunosuppression; or a history of known active hepatitis B or C infection are ineligible for enrollment on the trial. Patients are also ineligible for study entry if they have a history of active inflammatory bowel disease, active infections requiring management with antibiotic agents, major surgery within 28 days before randomization, or inadequate organ function.

References

1. Saudi FDA grants accelerated approval to ImmunityBio’s ANKTIVA in combination with checkpoint inhibitors for metastatic non-small cell lung cancer. News release. ImmunityBio Inc. January 14, 2026. Accessed January 14, 2026. https://tinyurl.com/mr2xvwmz
2. ImmunityBio announces positive results demonstrating ANKTIVA as a lymphocyte stimulating agent in combination with checkpoint inhibitors in non-small cell lung cancer. News release. ImmunityBio Inc. January 13, 2026. Accessed January 13, 2026. https://tinyurl.com/eauukmpx
3. ResQ201A: clinical trial of N-803 plus tislelizumab and docetaxel versus docetaxel monotherapy in participants with advanced or metastatic non-small cell lung cancer. ClinicalTrials.gov. Updated October 21, 2025. Accessed January 14, 2026. https://tinyurl.com/ycek8784