Lipzol ® combined with bevacizumab is approved in China for first-line maintenance therapy for HRD-positive advanced ovarian cancer

The approval is based on the results
of the PAOLA-1 Phase III pivotal trial.
PAOLA-1 met its primary endpoint, and in the ITT patient population, the risk of progression or death was reduced by 41% in the olaparib/bevacizumab group compared with the placebo/bevacizumab group (HR 0.
59; 95% CI 0.
49-0.
72; p< 0.
0001).

。 In HRD-positive patients, median PFS was extended by nearly 20 months in the olapalib/bevacizumab group compared with placebo/bevacizumab (median PFS 37.
2 versus 17.
7 months), with a 67% lower risk of progression or death (HR 0.
33; 95% CI 0.
25 to 0.
45).

。 The latest overall survival (OS) follow-up data were published at the 2022 European Society for Medical Oncology (ESMO): although about 50% of patients in the placebo combined with bevacizumab group cross-received PARP inhibitors after disease progression, olaparib combined with bevacizumab maintenance therapy still provided clinically meaningful OS improvement in HRD-positive patients, with a proportion of 5-year survivors as high as 65.
5%, and a 5-year OS rate increased by 17% compared with placebo plus bevacizumab group.
The risk of death was reduced by 38% (HR 0.
62; 95% CI 0.
45-0.
85)
。

Academician Martin of the Chinese Academy of Engineering said: "The mortality rate of ovarian cancer ranks first among gynecological malignant tumors in China, and the emergence of PARP inhibitors and their application in first-line maintenance treatment programs for ovarian cancer may bring a new dawn to delay recurrence, prolong patient survival and improve cure
.
" In the PAOLA-1 clinical trial, olaparib in combination with bevacizumab provided clinically significant OS improvement in HRD-positive patients and a new option
for first-line maintenance therapy.
”

Professor Kong Beihua, Chairman of the Gynecologic Oncology Branch of the Chinese Medical Association, said: "Ovarian cancer has entered the era of precision treatment, and HRD detection (including BRCA1/2 mutation) has important clinical value for newly diagnosed patients with advanced ovarian cancer, which provides a basis
for the selection of subsequent treatment options and prognosis judgment.
The approval of the combination of olaparib and bevacizumab has brought clear survival benefits to HRD-positive patients and further demonstrated the importance of
precision diagnosis and treatment in the field of ovarian cancer.
”

Mr.
Wang Lei, Executive Vice President, International Business and China President, AstraZeneca, said, "As the first approved PARP inhibitor in China, olaparib has ushered in the era
of targeted therapy for advanced ovarian cancer.
Today's approval of the indication for first-line maintenance therapy to further expand the beneficiary population is another milestone in the treatment of ovarian cancer in China, fully demonstrating that AstraZeneca's commitment to the value of 'patient-centric' continues to bring high-quality innovative drugs to more patients
.
" In the future, we will continue to work with the government and industry partners to explore solutions for the whole course of the disease for patients and help improve the diagnosis and treatment of
Chinese women's cancer.
" ”

Ms.
Anna Tian, Senior Vice President of Merck and President of Merck China, said, "We are very pleased to see that since the initial approval in 2018, olaparib has been approved for a total of 4 indications in China, including this newly approved indication, a total of 3 related indications for the treatment
of patients with advanced ovarian cancer.
Women's health is related to the stability of their families and society behind them, and we will continue to work with all parties, including industry partners, to improve access to innovative medicines, create an era where cancer can be treated and cured, and jointly protect the health of thousands of
Chinese women.
" ”

Olaparib is an important result of
the strategic cooperation between AstraZeneca and Merck on innovative oncology drugs.
Olaparib was first approved in China in August 2018 for maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer, and again in China in December 2019 for first-line maintenance therapy
for advanced ovarian cancer with BRCA mutation.
In June 2021, olaparib was approved for the first indication for prostate cancer in China for the treatment of adult patients with metastatic castration-resistant prostate cancer who carry germline or somatic BRCA mutations and have failed previous treatment
.

About ovarian cancer

Ovarian cancer is the eighth most common cancer in women ^worldwide1
.
According to statistics, there were 55,342 new cases of ovarian cancer and 37,519 deaths in China in 202022222^.

In the past 10 years, the incidence of ovarian cancer in China has increased by 30%, and the mortality rate has increased by 18%.

Among gynecological malignancies, the incidence of ovarian cancer is second only to cervical cancer and endometrial cancer, but the 3-year survival rate is the lowest, only 39%³, and the 5-year recurrence rate is the highest, reaching 70%⁴
.
The main goal of first-line therapy is to delay disease progression as much as possible to achieve long-term ^remission5,6
.

About PAOLA-1

PAOLA-1 is a randomized, double-blind, placebo-controlled, multicenter pivotal phase III study sponsored by ARCAGY Research on behalf of the European Network of Gynaecological Oncology Trials (ENGOT) and the Collaborative Group on Gynaecological Cancer (GCIG) to investigate the newly diagnosed advanced (FIGO stage III-IV) high-grade serous or endometrial ovarian cancer that achieves remission after platinum-containing chemotherapy plus bevacizumab first-line therapy compared with placebo, Efficacy and safety
of bevacizumab bevacizumab as first-line maintenance therapy in patients with tubal cancer or primary peritoneal cancer.
AstraZeneca and Merck announced in August 2019 that the trial met the primary endpoint PFS
in the entire trial population.

About olaparib

Olaparib is the world's first PARP inhibitor and the first targeted therapy to block the DNA damage repair pathway (DDR) in cells/tumors that block homologous recombinant repair (HRR) defects such as BRCA1 and/or BRCA2 mutations, or defects caused by other drugs such as novel endocrine drugs
.

Inhibition of the PARP protein with olaparib can lead to the capture of PARP bound to DNA single-strand breaks, replication fork arrest, collapse, and the production of DNA double-strand breaks and tumor cell death
.

Olaparib is currently approved in multiple countries across multiple tumor types, including maintenance therapy for platinum-sensitive recurrent ovarian cancer, and single-agent or in combination bevacizumab for first-line maintenance therapy for BRCA mutation (BRCAm) or HRD-positive advanced ovarian cancer
.

statement

It is for informational purposes only and is not used for any promotional purpose
.
If in doubt, consult a healthcare professional
.

References:

1.
World Cancer Research Fund International.
Ovarian Cancer Statistics.
Available at #:~:text=Latest%20ovarian%20cancer%20data,of%20ovarian%20cancer%20in%202020.
Accessed September 2022.

2.
https://gco.
iarc.
fr/today/data/factsheets/populations/160-china-fact-sheets.
pdf

3.
Hongmei Zeng, et al.
Changing cancer survival in China during 2003–15: a pooled analysis of 17 population-based cancer registries[J].
Lancet Glob Health 2018; 6: e555–67.

4.
Ledermann JA, Raja FA, Fotopoulou C, Gonzalez-Martin A, Colombo N, Sessa C.
Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up [J].
Ann Oncol 2013; 24:Suppl 6:vi24-vi32

5.
Raja F, et al.
Optimal first-line treatment in ovarian cancer.
Ann of Oncol.
2012; 23(10):118-127.

6.
NHS Choices, Ovarian Cancer Available at  September 2022.