AstraZeneca’s immunotherapy Imfinzi (ingredient: durvalumab) has obtained local approval for small-cell lung cancer (SCLC), which causes a poor prognosis.
The Ministry of Food and Drug Safety on June 8 granted the nod for Imfinzi as the first-line treatment for patients with extensive-stage SCLC in combination with chemotherapy.
Korea became the third country, after Singapore and the U.S., to approve Imfinzi to treat SCLC.
The latest expansion of the indication was based on the phase-3 CASPIAN study that compared the Imfinzi plus chemotherapy with the standard of care in patients with extensive-stage SCLC how have not been treated previously in 22 countries.
The results showed that Imfinzi in combo with chemo (etoposide plus either carboplatin or cisplatin) in four cycles demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus the standard of care in six cycles.
In the Imfinzi with chemo group, the risk of death was reduced by 27 percent, with a median OS of 13 months versus 10.3 months for chemotherapy alone.
The combo therapy group also showed better results in progression-free survival (PFS) and objective response rate (ORR) at 12-month of the follow-up.
Imfinzi’s safety profile was consistent with the previous ones reported in the existing studies, the company said.
In terms of adverse events, 61.5 percent of the combined treatment group and 62.4 percent of the control group experienced moderate or severe (Grade 3 or 4) adverse events. The number of patients who discontinued the treatment due to adverse events was similar among the two arms.