AstraZeneca (AZN) has announced that its Imfinzi (durvalumab) treatment has been approved in Japan for extensive-stage small cell lung cancer (ES-SCLC), with etoposide plus platinum chemotherapy (either carboplatin or cisplatin).
SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.
The approval was based on positive results from the Phase III CASPIAN trial, showing Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone.It reduced the risk of death by 27% versus chemotherapy alone, with median OS of 13.0 months versus 10.3 months for chemotherapy alone.
Makoto Nishio, an investigator in the trial, said: “Patients with extensive-stage small cell lung cancer in Japan are in urgent need of new options that can provide long-term tumor control and sustained improvements in overall survival.”
He continued: “This approval provides Japanese patients with a new, effective and well-tolerated 1st-line treatment option for this disease, and for the first time physicians have the opportunity to combine immunotherapy with cisplatin for these patients.”
Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is also approved in the US and several other countries for ES-SCLC in the 1st-line setting and is currently under regulatory review in other countries. It was recently recommended for marketing authorisation in the EU for this indication.
It is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial.
AstraZeneca shares have advanced 13% this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. Looking ahead, the $81.84 average analyst price target puts the upside potential at a promising 45% in the coming 12 months.
Overall, the stock scores a Strong Buy consensus from the analyst community based on 3 unanimous Buy ratings. (See AstraZeneca stock analysis on TipRanks)
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