ImmunityBio, BeiGene Strike Deal to Conduct Phase III Trial for Tislelizumab, Anktiva in Advanced or Metastatic Non-Small Cell Lung Cancer

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ImmunityBio has entered a collaboration and supply agreement with BeiGene to conduct a confirmatory Phase III trial to evaluate the combination of tislelizumab, BeiGene’s PD-1 checkpoint inhibitor (CPI), and ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have developed a resistance to CPIs. According to ImmunityBio, the trial will be guided by data from the QUILT 3.055 study, which indicated that Anktiva can restore T-cell function and improve overall survival (OS) in CPI-resistant patients.¹

“The challenge oncologists face in the next five years is how to manage the many patients who do not respond to CPI therapy after an initial response,” said Patrick Soon-Shiong, founder, executive chairman, global chief scientific and medical officer, ImmunityBio, im a press release. “Currently, options are limited for these second- and third-line patients with NSCLC whose cancer continues to progress on CPIs. The finding that these ‘cold’ tumors, which have evaded T cells, can now be rendered ‘hot’ through the activation of natural killer cells with Anktiva is exciting. To our knowledge, Anktiva is the first approved cytokine to address low white cell count (lymphopenia), which occurs following chemo-immunotherapy and radiotherapy. On the basis of Anktiva’s mechanism of action of proliferating T cells as well as NK cells, Anktiva has the potential to serve as the foundational cytokine to address loss of activity in the multiple tumors in which CPIs are approved.”

The ResQ201A-NSCLC trial is expected to enroll approximately 462 patients across multiple sites globally. The trial’s primary endpoint is OS, with key secondary endpoints that include disease control rate, progression-free survival, objective response rate, and safety.

According to ImmunityBio, Phase I and II data suggest that approach extends median OS beyond historical chemotherapy results, with QUILT 3.055 reporting a median OS of 14.1 months. Additionally, the combination of Anktiva and tislelizumab demonstrated a median OS of 17.1 months in patients with PD-L1 ≥ 50%, while patients who relapsed on checkpoint inhibitor therapy demonstrated a median OS of 19.6 months.¹

Statistics from the American Cancer Society indicate that approximately 226,650 people will be diagnosed with lung cancer in the United States this year, with approximately 124,730 deaths. Lung cancer mainly occurs in older people, with a median diagnosis age of 70 years. However, a small number of people can be diagnosed under 45 years of age. Despite being the second most common cancer in the Unites States, it is the leading cause of cancer-related deaths, accounting for more fatalities than colon, breast, and prostate cancers combined. In men, only prostate cancer is more common while in women, only breast cancer is more common.

Men have a one in 17 chance of developing lung cancer. On the other hand, women have a one in 18 chance, including both smokers and non-smokers.²

“ImmunityBio and BeiGene share a similar vision to advance the next generation of oncology immunotherapies to address unmet needs. We are excited to explore the potential of our PD-1 inhibitor, tislelizumab, in combination with Anktiva,” said John V. Oyler, co-founder, chairman, CEO, BeiGene, in the press release. “I’ve admired Dr. Soon-Shiong’s bold approach to medicine and look forward to working with him and his team as the ResQ201A-NSCLC study gets underway. Together, we hope to help metastatic lung cancer patients who may have few options left.”

References

1. ImmunityBio Announces Collaboration with BeiGene on Confirmatory Phase 3 Trial of ANKTIVA® and PD-1 Checkpoint Inhibitor Combination in Non-Small Cell Lung Cancer. ImmunityBio. January 29, 2025. Accessed January 30, 2025. https://immunitybio.com/immunitybio-announces-collaboration-with-beigene-on-confirmatory-phase-3-trial-of-anktiva-and-pd-1-checkpoint-inhibitor-combination-in-non-small-cell-lung-cancer/

2. Key Statistics for Lung Cancer. American Cancer Society. Accessed January 30, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html