NMPA approves Imfinzi for AstraZeneca's small cell lung cancer immunotherapy

July 19, the State Drug Administration Bureau (NMPA) approved the Imfinzi (durvalumab) developed by AstraZeneca for the treatment of extensive-stage small cell lung cancer immune therapy
.

Management Immunity

AstraZeneca stated that the approval of the China National Medical Products Administration is based on the positive results of the Caspian Phase III trial
.

Tests have shown that compared with chemotherapy alone, Imfinzi combined with chemotherapy has a significant and clinically significant improvement in overall survival

The trial was conducted in more than 200 centers in 23 countries, including a group of Chinese patients.
The primary endpoint of overall survival was reached in June 2019.
The trial showed that Imfinzi plus chemotherapy has a lower risk of death compared with chemotherapy alone.
That’s 27%
.

An updated analysis shows that the therapy continues to be effective for patients after an average of more than two years

The latest analysis of CASPIAN data shows that after a median follow-up of more than two years, Imfinzi plus chemotherapy has a sustained effect, and the overall risk of death is reduced by 25%
.

The median overall survival of AZ drugs was 12.

The research led to the US approval of Imfinzi in the same indication last year, and a market war with Roche’s PD-1/PD-L1 inhibitor Tecentriq (atezolizumab), which was also approved for SCLC
.

Tecentriq has been approved for SCLC in China, but AZ stated that Imfinzi is the only drug in the PD-1/PD-L1 category that shows significant survival benefits when used in combination with cisplatin and carboplatin

"This is also the first time a doctor has chosen to combine immunotherapy with cisplatin.
Cisplatin is the first choice for chemotherapy in this situation in China," commented Dave Fredrickson, head of AZ's oncology business unit
.

Roche's IMpower 133 study on Tecentriq in an extensive SCLC focused on the first-line use of the drug with carboplatin and etoposide
.

AZ and Roche are currently in competition for this indication, because in the KEYNOTE-604 trial, Merck’s competitor drug Keytruda, which dominates the NSCLC market, failed to show efficacy in newly diagnosed SCLC

NSCLC diagnosis

Lung cancer accounts for about one-fifth of all cancer deaths and is the leading cause of cancer deaths in men and women
.

China has a high incidence of lung cancer in the world, partly because despite efforts to curb tobacco use, smoking rates are still high

Leave a message here