# AstraZeneca’s Imfinzi approved in China for extensive-stage SCLC

- Link: https://www.directorstalkinterviews.com/astrazenecas-imfinzi-approved-in-china-for-extensive-stage-sclc/4121010535
- Published: 2021-07-19T07:31:30+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Imfinzi_ (durvalumab) has been approved in China for the 1st-line treatment of 
adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination
with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin
or cisplatin).

The approval by China’s National Medical Products Administration was based on positive
results from the CASPIAN Phase III trial. The trial showed that _Imfinzi_ plus chemotherapy
demonstrated a statistically significant and clinically meaningful improvement in
overall survival (OS) versus chemotherapy alone. In addition, results from the China
cohort of patients were consistent with the global results.

Small cell lung cancer (SCLC) is a highly aggressive, fast-growing form of lung 
cancer that typically recurs and progresses rapidly despite initial response to 
chemotherapy.^(1,2) Prognosis is particularly poor, as only 7% of all SCLC patients
and 3% of those with extensive-stage disease will be alive five years after diagnosis.
^(3)

> **Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: **“
> Today’s approval of _Imfinzi_ plus chemotherapy brings an important global standard
> of care to patients with extensive-stage small cell lung cancer in China, who 
> have had few treatment options and a dire prognosis. Physicians can now offer 
> these patients a well-tolerated immunotherapy regimen with sustained overall survival
> and prolonged treatment response, as well as convenient dosing. This is also the
> first time physicians have had the choice to combine immunotherapy with cisplatin,
> a preferred chemotherapy in this setting in China.”

The CASPIAN Phase III trial met the primary endpoint of OS for _Imfinzi_ plus chemotherapy
in June 2019, reducing the risk of death by 27% versus chemotherapy alone (based
on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047),
with a median OS of 13.0 months versus 10.3 months for chemotherapy alone. These
results were published in The Lancet in October 2019.^(4) Results also showed an
increased confirmed objective response rate for _Imfinzi_ plus chemotherapy (68%
versus 58% for chemotherapy alone). _Imfinzi_ added to chemotherapy delayed the 
time for disease symptoms to worsen.^(4)

An updated analysis showed sustained efficacy for _Imfinzi_ plus chemotherapy after
a median follow up of more than two years (OS HR of 0.75; 95% CI 0.62-0.91; nominal
p=0.0032), with median OS of 12.9 months versus 10.5 months for chemotherapy alone.
An estimated 22.2% of patients treated with _Imfinzi_ plus chemotherapy were alive
at 24 months versus 14.4% for chemotherapy alone. The safety and tolerability for
_Imfinzi_ and chemotherapy were consistent with the known safety profiles of these
medicines. No patients tested positive for treatment-emergent anti-drug antibodies
to _Imfinzi_.

Safety and efficacy results in the China cohort of patients were consistent with
results in the overall global trial population. Detailed results from this cohort
will be presented at a forthcoming medical meeting.

The CASPIAN Phase III trial used a fixed dose of _Imfinzi_ (1500mg) administered
every three weeks for four cycles while in combination with chemotherapy and then
every four weeks as a monotherapy until disease progression. Based on the trial 
results, _Imfinzi_, in combination with etoposide and either carboplatin or cisplatin,
is approved in the 1st-line setting of ES-SCLC in more than 55 countries, including
the US, Japan and across the EU.

_Imfinzi_ is also being tested following concurrent chemoradiation therapy in patients
with limited-stage SCLC in the ADRIATIC Phase III trial as part of a broad development
programme. In addition, _Imfinzi_ is also approved to treat non-small cell lung 
cancer (NSCLC) in the curative-intent setting of unresectable, Stage III disease
after chemoradiation therapy in the US, Japan, China, across the EU and in many 
other countries, based on results from the PACIFIC Phase III trial.

**Small cell lung cancer**

Lung cancer is the leading cause of cancer death among men and women and accounts
for about one-fifth of all cancer deaths.^(5) Lung cancer is broadly split into 
NSCLC and SCLC, with about 15% classified as SCLC.^(6) About two-thirds of SCLC 
patients are diagnosed with extensive-stage disease, in which the cancer has spread
widely through the lung or to other parts of the body.^(3)

**CASPIAN**

CASPIAN was a randomised, open-label, multi-centre, global Phase III trial in the
1st-line treatment of 805 patients with ES-SCLC. The trial compared _Imfinzi_ in
combination with etoposide and either carboplatin or cisplatin platinum chemotherapy,
or _Imfinzi_ and chemotherapy with the addition of a second immunotherapy, tremelimumab,
versus chemotherapy alone. In the two experimental arms, patients were treated with
four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles
of chemotherapy and optional prophylactic cranial irradiation.

The trial was conducted in more than 200 centres across 23 countries, including 
the US, Europe, South America, Asia and the Middle East. The primary endpoint was
OS in each of the two experimental arms. In June 2019, AstraZeneca announced the
CASPIAN Phase III trial had met one primary endpoint of demonstrating OS for _Imfinzi_
plus chemotherapy at a planned interim analysis. In March 2020, however, it was 
announced that the second experimental arm with tremelimumab did not meet its primary
endpoint of OS.

**Imfinzi**

_Imfinzi_ (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks
the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading
tactics and releasing the inhibition of immune responses.

In addition to approvals in ES-SCLC and unresectable, Stage III NSCLC, _Imfinzi_
is approved for previously treated patients with advanced bladder cancer in several
countries. Since the first approval in May 2017, more than 100,000 patients have
been treated with _Imfinzi_.

As part of a broad development programme, _Imfinzi_ is being tested as a single 
treatment and in combinations with other anti-cancer treatments for patients with
NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer (a form
of liver cancer), oesophageal cancer, gastric and gastroesophageal cancer, cervical
cancer, ovarian cancer, endometrial cancer, and other solid tumours.

**AstraZeneca in lung cancer**

AstraZeneca is working to bring patients with lung cancer closer to cure through
the detection and treatment of early-stage disease, while also pushing the boundaries
of science to improve outcomes in the resistant and advanced settings. By defining
new therapeutic targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and
the next wave of innovations, including _Tagrisso_ (osimertinib) and _Iressa_ (gefitinib);
_Imfinzi_ (durvalumab) and tremelimumab; _Enhertu_ (trastuzumab deruxtecan) and 
datopotamab deruxtecan in collaboration with Daiichi Sankyo; _Orpathys_ (savolitinib)
in collaboration with HUTCHMED; as well as a pipeline of potential new medicines
and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition
working to accelerate innovation and deliver meaningful improvements for people 
with lung cancer, including and beyond treatment.

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