# AstraZeneca’s Imfinzi plus chemotherapy significantly improved pathologic complete response

- Link: https://www.directorstalkinterviews.com/astrazenecas-imfinzi-plus-chemotherapy-significantly-improved-pathologic-complete-response/4121070779
- Published: 2022-06-30T08:19:18+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_ plus chemotherapy significantly improved pathologic complete response 
in AEGEAN Phase III trial in resectable non-small cell lung cancer.

Positive high-level results from a planned interim analysis of the AEGEAN Phase 
III trial showed treatment with AstraZeneca’s _Imfinzi_ (durvalumab) in combination
with neoadjuvant chemotherapy before surgery demonstrated a statistically significant
and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant
chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC).

A statistically significant improvement in major pathologic response (MPR) was also
observed. The trial will continue as planned to assess the additional primary endpoint
of event-free survival (EFS) to which the Company, investigators and participants
remain blinded.

The safety and tolerability of adding _Imfinzi_ to neoadjuvant chemotherapy was 
consistent with the known profile for this combination and did not decrease the 
number of patients able to undergo successful surgery versus chemotherapy alone.

Up to 30% of all patients globally with NSCLC are diagnosed early enough to have
surgery with curative intent.^(1-3) However, only around 56-65% of patients with
Stage II disease will survive for five-years. This decreases to 24-41% for patients
with Stage III disease.^(4)

These pCR data will be shared with global health authorities and presented at a 
forthcoming medical meeting when EFS results are available.

AstraZeneca has several ongoing registrational trials focused on testing _Imfinzi_
in earlier stages of lung cancer, including in resectable NSCLC (ADJUVANT BR.31)
and unresectable NSCLC (PACIFIC-2, 4, 5, 8 and 9), and in limited-stage small cell
lung cancer (SCLC) (ADRIATIC).

_Imfinzi_ is approved in the curative-intent setting of unresectable Stage III NSCLC
in patients whose disease has not progressed after chemoradiotherapy in the US, 
Japan, China, across the EU and many other countries, and is the global standard
of care in this setting based on the PACIFIC Phase III trial. _Imfinzi_ is also 
approved in the US, EU, Japan, China and many other countries around the world for
the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial.

**Notes**

**Lung cancer**

In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide.
^(5) Lung cancer is the leading cause of cancer mortality among men and women and
accounts for about one-fifth of all cancer-related deaths.^(5) Lung cancer is broadly
split into NSCLC and SCLC, with 80-85% classified as NSCLC.^(6) The majority of 
NSCLC patients are diagnosed with advanced disease while approximately 25-30% present
with resectable disease at diagnosis. ^(1-2) Early-stage lung cancer diagnoses are
often only made when the cancer is found on imaging for an unrelated condition.^(
7-8)

For patients with resectable tumours, the majority of patients eventually develop
recurrence despite complete tumour resection and adjuvant chemotherapy.

**AEGEAN**

AEGEAN is a randomised, double-blind, multi-centre, global Phase III trial evaluating
_Imfinzi_ as perioperative treatment for patients with resectable Stage IIA-IIIB(
tumours greater than or equal to 4cm or node positive) NSCLC with no EGFR or ALK
genomic tumour aberrations, irrespective of PD-L1 expression. Perioperative therapy
includes treatment before and after surgery, also known as neoadjuvant/adjuvant 
therapy. In the trial, 802 patients were randomised to receive a 1500mg fixed dose
of _Imfinzi_ every three weeks plus chemotherapy or placebo plus chemotherapy for
four cycles prior to surgery, followed by _Imfinzi_ or placebo every four weeks (
for up to 12 cycles) after surgery.

In the AEGEAN trial, the primary endpoints are pCR, defined as no viable tumour 
following neoadjuvant therapy, and EFS, defined as the time from randomisation to
an event like tumour recurrence or progression. At this interim analysis EFS was
not assessed. Key secondary endpoints are MPR, defined as residual viable tumour
of less than or equal to ten percent following neoadjuvant therapy, disease-free
survival, overall survival, safety and quality of life. The trial is being conducted
across 264 centres in more than 25 countries including in the US, Canada, Europe,
South America and Asia.

**_Imfinzi_**

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

As well as global approvals in lung cancer, _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
SCLC, NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer
and other solid tumours.

In the past year, _Imfinzi _combinations have resulted in positive Phase III trials
in multiple additional cancer settings including; unresectable advanced liver cancer(
HIMALAYA), biliary tract cancer (TOPAZ-1) and metastatic NSCLC (POSEIDON) and the
data are under review with global health authorities.

> **Susan Galbraith, Executive Vice President, AstraZeneca Oncology R&D, said: **”
> Treating resectable lung cancer early provides the best chance for a cure, yet
> lung cancer will still recur within five years for the majority of patients despite
> chemotherapy and successful surgery. Engaging the immune response with _Imfinzi_
> both before and after surgery is an exciting new strategy, and we hope these early
> findings from AEGEAN will lead to improved survival for lung cancer patients in
> this potentially curative setting.”

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