FDA Approves Tremelimumab Plus Durvalumab for Advanced NSCLC

Approval Alert | <b>Tremelimumab Plus Durvalumab and Chemotherapy in Advanced Non–Small Cell Lung Cancer</b>

The FDA has approved tremelimumab plus durvalumab for patients with metastatic non–small cell lung cancer based on findings from arms 1 and 3 of the phase 3 POSEIDON trial.

The FDA approved tremelimumab (Imjudo) plus durvalumab (Imfinzi) and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer who have an EGFR mutation or ALK alteration, according to a press release from the agency.

The FDA’s approval was based on results from the phase 3 POSEIDON trial (NCT03164616) and included arm 1, the approved indication, and arm 3 which was standard of care chemotherapy alone. Patients (n = 675) were randomized 1:1:1 and were treated with tremelimumab plus durvalumab and chemotherapy for 4 cycles then durvalumab plus chemotherapy every 4 weeks; or platinum-based chemotherapy for 6 cycles followed by maintenance chemotherapy.

In September, results of the POSEIDON trial showed that tremelimumab, when added to frontline durvalumab plus chemotherapy, prolonged overall survival (OS) in patients after 4 years of follow-up.

The recommended treatment dose for patients who weighed 30 kg or more receiving tremelimumab was 75 mg intravenously every 3 weeks plus durvalumab at 1500 mg intravenously with chemotherapy for 4 cycles then durvalumab at 15 mg and maintenance chemotherapy every 4 weeks. If patients received a fifth dose of 75 mg of tremelimumab, it should be given at week 16. If patients weighed less than 30 kg, they should receive 1 mg/kg of tremelimumab and 20 mg/kg of durvalumab.

A statistically significant and meaningful improvement in overall survival (OS) was observed in the treatment arm (HR, 0.77; 95% CI: 0.65, 0.92; 2-sided P value = .00304). The median OS in the tremelimumab plus durvalumab arm was 14 months (95% CI, 11.7-16.1) and in the chemotherapy arm it was 11.7 months (95% CI, 10.5-13.1). The median progression-free survival in the tremelimumab arm was 6.2 months (95% CI, 5.0-6.5) compared with 4.8 months (95% CI, 4.6-5.8) in the chemotherapy arm (HR, 0.72; 95% CI, 0.60-0.86; 2-sided P value = .00031).

Between the tremelimumab plus durvalumab and chemotherapy arms, the overall response rate was 39% (95% CI, 34%-44%) and 24% (95% CI, 20%-29%), respectively. As for the median duration of response, treatment with the tremelimumab and durvalumab-based combination resulted in superior outcome at 9.5 months (95% CI, 7.2- not reached) versus 5.1 months (95% CI, 4.4-6.0), respectively.

Grade 3/4 adverse effects that were most common (≥ 10%) were mostly laboratory abnormalities) that included neutropenia, anemia, leukopenia, lymphocytopenia, lipase increased, hyponatremia, and thrombocytopenia.


FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. FDA. November 10, 2022. Accessed November 10, 2022. https://bit.ly/3Us5sf8