1. Penpulimab-kcqx extended progression-free survival to 9.6 months compared to chemotherapy alone in nonkeratinizing nasopharyngeal carcinoma.
2. Approval by the FDA was for both combination and monotherapy treatments.
3. Fast track, breakthrough therapy, orphan drug designations were received.
4. Immune-mediated adverse events associated with penpulimab-kcqx included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin reactions.
5. The most common adverse events in the combination setting were nausea, hypothyroidism, fatigue, rash, and COVID-19 infection; as monotherapy, the most frequent events were hypothyroidism and musculoskeletal pain.

Source: FDA