ImmunityBio Surges 27% on Plan to File IL-15 Therapy Anktiva for NSCLC in 2025

▎Armstrong

On January 15, 2025, ImmunityBio updated the progress of its R&D pipeline. The sBLA for the core pipeline IL-15 new drug Anktiva for the treatment of papillary NMIBC will be submitted in 2025, and the marketing applications for second-line and third-line treatments of NSCLC will also be submitted in 2025.

Affected by this news, ImmunityBio's stock price surged 27% on the same day, with a current market value of $2.2 billion.

Anktiva was approved for marketing by the FDA in April last year and is currently actively expanding to more tumor types.

Tumor immunotherapy represented by PD-1 has brought breakthrough progress in cancer treatment, but there remains a significant clinical gap in the treatment after PD-1 resistance.

After NSCLC patients develop resistance to first-line treatment with PD-1±chemotherapy, the overall prognosis is poor, with an overall survival of less than 10 months. In Phase II clinical trials, the combination therapy of Anktiva+PD-1 achieved a median overall survival (mOS) of 14.1 months for NSCLC patients post-PD-1 treatment, with an 18-month survival rate of 33.7% and a 21-month survival rate of 31.4%. This indicates that Anktiva has the potential to reverse PD-1 resistance.

ImmunityBio is preparing for a Phase III clinical trial.

ImmunityBio Plans to Submit Anktiva+PD-1 Combination for Second-Line and Third-Line Treatment of NSCLC After Immune Checkpoint Resistance in 2025.

The Phase III pivotal clinical trial is expected to read out data in the second half of 2027, with the marketing application for second-line treatment anticipated to be submitted in early 2028.

ImmunityBio also disclosed preliminary clinical data for colorectal cancer, with Anktiva + rituximab combination therapy achieving CR in 1 patient with CD20 sensitivity.

Summary

Cytokines Become Another Important Breakthrough in the Field of Immunotherapy.