Tifcemalimab Plus Toripalimab Demonstrated Promising Antitumor Activity For Refractory Extensive-Stage Small Cell Lung Cancer

According to phase 1/2 study results, tifcemalimab, a humanized IgG4 monoclonal antibody, plus toripalimab showed promising antitumor activity with a manageable safety profile among patients with refractory extensive-stage small cell lung cancer (SCLC). 

These results were first presented by Liang Zhang, MD, Jilin Cancer Hospital, Changchun, China at the 2024 World Conference on Lung Cancer. 

In this study, researchers enrolled 43 patients who were refractory to prior systemic therapies to receive 200 mg of tifcemalimab plus 240 mg of toripalimab once every 3 weeks until disease progression, unacceptable toxicity, or for up to 2 years. The primary end points were safety and objective response rate (ORR). Secondary end points included duration of response (DOR), progression-free survival (PFS), and median overall survival (OS). 

At a median follow-up of 11.7 months, 90.7% of patients experienced treatment-emergent adverse events and 39.5% of patients experienced grade ≥3 treatment-emergent adverse events. The most common events included anemia (25.6%), blood creatine phosphokinase increase (25.6%), alanine aminotransferase increase (23.3%), COVID-19 (23.3%), hyperglycemia (23.3%), hyponatremia (20.9%), and hypothyroidism (20.9%). Treatment-emergent adverse events led to treatment interruption in 25.6% of patients. There were no events treatment discontinuations due to adverse events. Immune-related adverse events were observed in 41.9% of patients, and 9.3% of patients experienced grade ≥3 immune-related adverse events. 

Among 40 patients eligible for efficacy evaluation, the ORR was 32.6% and the disease control rate was 51.2%. The DOR was 5.7 months. The median PFS was 2.8 months and the median OS was 12.3 months. 

“Tifcemalimab in combination with toripalimab showed promising antitumor activity with manageable toxicity in patients with refractory ES-SCLC,” concluded Dr Cheng. “Further clinical evaluation of this combination treatment in SCLC is warranted.” 

Source: 

Cheng Y, Wang J, Yu Y, et al. Safety and efficacy of tifcemalimab combined with toripalimab in refractory extensive stage small cell lung cancer. Presented at the World Conference on Lung Cancer; September 7-10, 2024. San Diego, CA. Abstract #MA17.08