Lung cancer is heavy! AstraZenecom Imfinzi (Infinfan) has been approved by Japan: first-line treatment of extensive stage small cell lung cancer (ES-SCLC)!

!--, 2020 // -- AstraZeneca recently announced that Japanese regulators have approved anti-PD-L1 therapy Imfinzi. Feifan, common name: durvalumab, dvaliyu monoanti), joint standard care (SoC) with platinum chemotherapy (etoposide plus carbatin, or etoposide plus cisplatin), first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC).
approval will provide an important first-line treatment for the ES-SCLC patient population in Japan.
SCLC is an invasive, fast-growing cancer that, although initially responded to platinum-containing chemotherapy, usually relapses and progresses quickly.
U.S., Imfinzi received FDA approval at the end of March 2020 to treat adult patients with ES-SCLC in combination with platinum-containing chemotherapy (etoposide plus carbaptin or etoposide plus cisplatin).
, the allergy is also under regulatory review by the European Medicines Agency (EMA).
it is worth noting that Imfinzi is the only PD-1/PD-L1 immunotherapy that has been shown to provide significant survival benefits and improve remission rates in combination with SoC-containing platinum chemotherapy (etoposide plus cisplatin or carbaptin).
approval is based on the results of the Phase III CASPIAN trial.
data have been published in the Lancet, the world's top medical journal.
data show that the combination of fixed-dose Imfinzi and SoC-containing platinum chemotherapy showed statistically and clinically significant improvements in total lifetime (OS) compared to standard care (SoC) platinum-containing chemotherapy. "In Japan, there is an urgent need for patients with broad-stage small cell lung cancer (ES-SCLC) to be able to provide new treatment options for long-term tumor control and continuous improvement in total survival," said Dr. Makoto Nishio, an investigator on the
CASPIAN study and director of thoracic oncology at the Cancer Institute of the Japan Cancer Research Foundation.
this approval of Imfinzi provides Japanese patients with a new, effective and well-to-bear first-line treatment, and doctors have the first opportunity to combine immunotherapy with cisplatin to treat these patients.
dave Fredrickson, executive vice president of AstraZeneta's oncology business unit, said: "Imfinzi's approval provides an important new immunotherapy option for patients with extensive stage small cell lung cancer (ES-SCLC) in Japan.
the prognosis of these patients was particularly poor, with only 2% surviving for more than five years.
combination of Imfinzi and chemotherapy, a convenient dosing program given every four weeks during maintenance can provide sustained survival benefits and extend treatment response times.
"CASPIAN is a randomized, open-label, multi-center, global Phase III study that compares the efficacy and safety of Ifinzi-SoC-containing platinum chemotherapy (etoposide-cisplatin or carp platinum), Imfinzi-tremelimumab-SoC-containing platinum chemotherapy, and SoC platinum-containing chemotherapy first-line treatment of ES-SCLC patients.
, the Imfinzi-tremelimumab-SoC platinum-containing chemotherapy combination is a dual immuno-checkpoint blocking combination chemotherapy programme consisting of CTLA4 checkpoint inhibitor tremelimumab (an anti-CTLA4 monoant), PD-L1 checkpoint inhibitor Imfinzi (an anti-PD-L1 monoantigen) and SoC chemotherapy.
study, Imfinzi was given a fixed dose (1500 mg), given once every three weeks, and treated for four cycles, with patients in the experimental group receiving up to four cycles of SoC chemotherapy and the control group allowing up to six cycles of SoC chemotherapy and preventive brain radiation therapy (PCI).
the study was conducted at more than 200 clinical centers in 22 countries, including the United States, Europe, South America, Asia and the Middle East.
end point is total lifetime (OS).
June 2019, the CASPIAN trial reached a major end point: a planned interim analysis by the Independent Data Monitoring Board (IDMC) showed a 27% reduction in the risk of death in the Imfinzi-SoC chemotherapy group compared to the SoC chemotherapy group (HR=0.73,95% CI:0.591-0.909 , p .0047), significantly longer total lifetime (medium OS: 13.0 months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
addition, the Imfinzi-SoC chemotherapy group showed treatment benefits compared to the SoC chemotherapy group at all therapeutic endpoints, including a significant increase in progression-free survival at 12 months (PFS rate: 17.5% vs. 4.7%), Increased objective remission rate confirmed at 12 months (ORR: 67.9% vs 57.6%) and increased proportion of patients with 12 months of continuous remission (DOR) (DOR:22.7% vs 6.3%).
analysis, published at the end of May 2020, showed that after more than 2 years of medium follow-up, imfinzi-SoC chemotherapy showed continuous efficacy, reducing the risk of death by 25% compared to SoC chemotherapy (HR=0.75; 95% CI:0.62-0.91; nominal p=0.0032).
12.9 months for the latest update and 10.5 months for the SoC chemotherapy group.
an after-the-fact analysis, the estimated 24-month survival rate was 22.2 percent in the Imfinzi-SoC chemotherapy group and 14.4 percent in the SoC chemotherapy group.
analysis showed that the 24-month non-progressed survival rate was 11 percent in the Imfinzi-SoC chemotherapy group and 2.9 percent in the SoC chemotherapy group.
addition, the Imfinzi-SoC chemotherapy group maintained a higher objective remission rate (ORR:68% vs 58%), and in the post-mortem analysis, the proportion of patients with a duration of 24 months was 13.5% in the Imfinzi-SoC chemotherapy group and 3.9% in the SoC chemotherapy group.
24 months, 12 percent of patients in the Imfinzi-SoC chemotherapy group continued to receive Imfinzi treatment.
!--/ewebeditor:page--!--ewebeditor:page"--based on the results of this study, Imfinzi is the first tumor immunotherapy to show survival benefits and improve lasting remission in ES-SCLC patients.
, it is worth noting that in the final analysis, the Imfinzi-tremelimumab-SoC scheme did not achieve the main statistically significant improvement in OS compared to SoC.
the study, the safety and tolerance of Imfinzi and tremelimumab were consistent with the known safety of these drugs.
lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth of all cancer deaths.
lung cancer is roughly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which SCLC accounts for about 15%.
two-thirds of SCLC patients are diagnosed with a widespread disease, in which cancer has spread widely to the entire lungs or to other parts of the body.
SCLC is an invasive, fast-growing cancer that relapses and progresses rapidly, despite initially responding to platinum-containing chemotherapy.
poor prognostics, with only 6% of SCLC patients still alive five years after diagnosis.
Imfinzi (Infinfan, Dovaliyu monoanti) is an humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and releasing suppressed immune responses.
To date, Imfinzi has been approved in more than 60 countries (including the United States, Japan, China, and the European Union as a whole) for the non-removable, phase III non-small cell lung cancer (NSCLC) patients who have not progressed after receiving platinum-based chemotherapy-based simultaneous radiotherapy.
addition, Imfinzi has been approved in more than 10 countries, including the United States, for patients with advanced bladder cancer who have previously received platinum-containing chemotherapy.
as part of a wide-ranging development of lung cancer, Imfinzi is also being tested in another Phase III clinical study, ADRIATIC, which is expected to be available in 2021 after SCLC patients were treated with synchronous chemotherapy (CCRT).
tremelimumab is a human monoclonal antibody that targets cytotoxic T lymphocyte antigen 4 (CTLA-4), blocks CTLA-4 activity, promotes T-cell activation, initiates tumor immune response, and promotes cancer cell death.
tremelimumab and Shishi Shiguibo have listed antibody drug Yeervoy (Ipimon monoanti) targeting the same target CTLA-4.
Currently, AstraZenecom is conducting a major clinical project to evaluate Imfinzi as a monotherapy and a combination therapy for NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, cervical cancer, bile duct cancer and other solid tumors.
() Original source: Imfinzi approved in Japan for the treatment of the out-of-the-stage cell lung cancer !--/ewebeditor:page--.