# AstraZeneca and MSD’s Lynparza approved in the EU for prostate cancer

- Link: https://www.directorstalkinterviews.com/astrazeneca-and-msds%c2%a0lynparza-approved-in-the-eu-for-prostate-cancer/4121095208
- Published: 2022-12-21T07:27:36+00:00
- 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))
and MSD’s _Lynparza_ (olaparib) in combination with abiraterone and prednisone or
prednisolone has been approved in the European Union for the treatment of metastatic
castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy 
is not clinically indicated.

This approval by the European Commission was based on results from the PROpel Phase
III trial and follows the positive recommendation in the EU by the Committee for
Medicinal Products for Human Use in November 2022.

In the trial, _Lynparza_ in combination with abiraterone and prednisone or prednisolone,
reduced the risk of disease progression or death by 34% versus abiraterone and prednisone
or prednisolone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [
CI] 0.54-0.81; p<0.0001). Median radiographic progression-free survival (rPFS) was
24.8 months for _Lynparza_ plus abiraterone versus 16.6 months for abiraterone alone.
Furthermore, a planned rPFS analysis by blinded independent central review (BICR)
showed _Lynparza_ plus abiraterone had a median rPFS of 27.6 months compared to 
16.4 months with abiraterone alone, extending median rPFS by almost one year.

Updated results from a second planned analysis presented at ESMO 2022 showed a favourable
trend towards improved overall survival with _Lynparza_ plus abiraterone versus 
abiraterone alone (based on HR of 0.83; 95% CI 0.66-1.03; p=0.11), however, the 
difference did not reach statistical significance at the time of this data cut-off(
analysis at 40% data maturity).

Prostate cancer is the most common cancer in men in Europe, with an estimated 473,000
patients diagnosed and 108,000 deaths in 2020.^(1,2) Overall survival for patients
with mCRPC is approximately three years in clinical trial settings, and even shorter
in the real-world.^(3) Approximately half of patients with mCRPC may receive only
one line of active treatment, with diminishing benefit of subsequent therapies.^(
4-9)

Noel Clarke, Urological Surgeon and Professor of Urological Oncology at Manchester’s
Christie/Salford Royal Hospitals and Manchester University, a senior investigator
of the PROpel trial, said: “The results of the PROpel Phase III trial of olaparib
in combination with abiraterone as a first-line treatment show that this therapeutic
combination can provide significant clinical benefit to patients with metastatic
castration-resistant prostate cancer. Patients with this condition in the EU will
now, for the first time, have the opportunity to benefit from this new treatment
combination.”

> **Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca,
> said**: “Many patients with metastatic castration-resistant prostate cancer are
> only able to receive one line of active therapy, as the disease can progress quickly.
> _Lynparza_ in combination with abiraterone has been shown to reduce the risk of
> disease progression by 34% versus the standard of care treatment in the PROpel
> trial. Moreover, the combination of _Lynparza_ with abiraterone as a first-line
> treatment expands the use of Lynparza to a broader group of metastatic castration-
> resistant prostate cancer patients than those treated with _Lynparza_ alone in
> the second-line setting in the PROfound trial. Today’s approval marks a significant
> advance toward addressing the unmet need of patients with metastatic castration-
> resistant prostate cancer in the EU.”

> **Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and
> Chief Medical Officer, MSD Research Laboratories, said**: “MSD is committed to
> developing new treatment options for patients with metastatic castration-resistant
> prostate cancer, a complex disease that urgently needs more therapies. This approval
> by the European Commission marks another step towards delivering on that commitment
> and we look forward to extending the benefits of _Lynparza_ to more patients with
> metastatic castration-resistant prostate cancer in the EU.”

The safety and tolerability of _Lynparza_ in combination with abiraterone in PROpel
was in line with that observed in prior clinical trials and the known profiles of
the individual medicines. There was no increase in the rate of discontinuation of
abiraterone in patients treated with _Lynparza_ in combination with abiraterone 
and no detrimental effect on health-related quality of life versus those treated
with abiraterone alone (Functional Assessment of Cancer Therapy-Prostate questionnaire).

In August, supplemental New Drug Application (sNDA) for _Lynparza _in combination
with abiraterone and prednisone or prednisolone was accepted and granted Priority
Review in the US for the treatment of adult patients with mCRPC. The Prescription
Drug User Fee Act (PDUFA) date is anticipated during the first quarter of 2023.

_Lynparza_ is approved in the US based on results from the PROfound Phase III trial
as monotherapy for patients with homologous recombination repair (HRR) gene-mutated
mCRPC (BRCA and other HRR gene mutations) who have progressed following prior treatment
with enzalutamide or abiraterone; and in the EU, Japan, and China for patients with
BRCA-mutated mCRPC who have progressed following prior therapy that included a new
hormonal agent.

**Financial considerations**

Following this approval for _Lynparza_ in the EU, AstraZeneca will receive a regulatory
milestone payment from MSD of $105m, anticipated to be booked as Collaboration Revenue
by the Company during the fourth quarter of 2022.

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