Qilu Pharmaceutical Launches Olaparib Tablets (Qipani®), Offering a New Maintenance Therapy Option for Ovarian Cancer Patients

Ovarian cancer is a malignant tumor that poses a serious threat to women's health. In recent years, the incidence of ovarian cancer in China has been on the rise. According to the statistical report from the National Cancer Center, there were approximately 61,100 new cases of ovarian cancer in China in 2022, with about 32,600 deaths.[1]。

Due to the lack of obvious early symptoms, about 70% of ovarian cancer patients are already in the advanced stage of the disease at the time of initial diagnosis and cannot undergo curative surgery.[2]; 70% of patients with advanced ovarian cancer survive no more than 5 years[3], 70% of ovarian cancer patients will relapse within 3 years after initial treatment.[4]。

The emergence of maintenance therapy for ovarian cancer has brought new hope for a cure to patients – undergoing maintenance therapy after first-line treatment is expected to delay tumor recurrence; while maintenance therapy during the platinum-sensitive recurrence phase is expected to postpone the time of recurrence again or reduce the risk of recurrence.[5]。

In recent years, the treatment landscape for ovarian cancer has developed rapidly. The maintenance therapy based on PARPi is a landmark event in the history of ovarian cancer diagnosis and treatment, making "surgery + platinum-based chemotherapy + maintenance therapy" the standard first-line treatment model for advanced ovarian cancer.[6-7]Based on a large number of high-level medical evidence, PARPi, including Olaparib, has now become the standard regimen for maintenance treatment of ovarian cancer unanimously recommended by guidelines and expert consensus both in China and internationally.

Olaparib is the world's first approved PARPi, and also the first PAPRi approved for first-line maintenance treatment of ovarian cancer in China and globally.[8], with rich evidence in evidence-based medicine and extensive clinical medication experience accumulated.

The SOLO-1 study is a global, multicenter, Phase III randomized, placebo-controlled clinical trial. The study demonstrated that, in newly diagnosed BRCA-mutated Stage III–IV ovarian cancer patients who achieved complete response or partial response (CR/PR) after initial treatment with surgery plus platinum-based chemotherapy, maintenance therapy with olaparib significantly extended progression-free survival (PFS) and overall survival (OS) compared to placebo treatment. Both high-risk and low-risk patients benefited from frontline maintenance therapy with olaparib. The 5-year follow-up results of the study showed that, compared to the placebo group, the olaparib group had a 67% reduction in the risk of disease progression or death, with a median PFS extended by 42.2 months (56.0 months vs. 13.8 months, HR=0.33), and a 27% increase in the 5-year PFS rate (48% vs. 21%).[9]In the Chinese cohort of the SOLO-1 study, consistent long-term clinical benefits were also observed.

PAOLA-1 Study is a global multicenter Phase III randomized, placebo-controlled clinical trial of olaparib combined with bevacizumab for first-line maintenance treatment of advanced ovarian cancer. The study confirmed that in newly diagnosed HRD-positive advanced ovarian cancer patients who achieved CR/PR after first-line surgery, platinum-based chemotherapy, and initial treatment with bevacizumab, maintenance treatment with olaparib plus bevacizumab (experimental group) significantly extended PFS and OS compared to placebo plus bevacizumab (control group); furthermore, regardless of BRCA status, PFS was significantly prolonged in patients.[10]。

The PAOLA-1/ENGOT-ov25 study stratified patients and included both "high-risk" and "low-risk" populations, further confirming the significant benefit of olaparib plus bevacizumab as first-line maintenance therapy for HRD-positive patients in both high-risk and low-risk groups. The 5-year follow-up results of the study showed that for HRD-positive patients receiving first-line maintenance therapy with olaparib plus bevacizumab, the median PFS was 46.8 months, which was 29.2 months longer than the control group (vs 17.6 months, HR=0.41), with a 26.9% increase in the 5-year PFS rate (46.1% vs 19.2%). The median OS reached 75.2 months (vs 57.3 months, HR=0.62), with a 17.1% increase in the 5-year OS rate (65.5% vs 48.4%).[11]。

SOLO2/ENGOT-Ov21 Study[12-13]A randomized, double-blind, placebo-controlled, multicenter Phase III clinical study enrolled 295 BRCA-mutated PSR ovarian cancer patients who achieved CR/PR after platinum-based chemotherapy to evaluate the efficacy of olaparib monotherapy as maintenance treatment. The results indicated that, compared with placebo, olaparib significantly reduced the risk of disease progression or death by 70% in BRCA-mutated PSR patients, significantly prolonging PFS (19.1 months vs 5.5 months) and OS (51.7 months vs 35.4 months).

In the field of maintenance treatment for ovarian cancer, multiple clinical studies have been conducted on olaparib.[9-13]，Fully verifying the long-term safety of Olaparib treatment, whether as a monotherapy or in combination with Bevacizumab, Olaparib demonstrates good tolerability in maintenance therapy, with most patients able to tolerate long-term treatment; even among PSR ovarian cancer patients, who may be in relatively poorer physical condition, over 90% can continue receiving Olaparib treatment until disease progression.[14-16]The safety advantages of Olaparib can better ensure the quality of life for patients and reduce the suffering caused by adverse reactions that lead to increased hospital visits.

Based on the unmet clinical needs of patients, Qilu Pharmaceutical has developed a generic version of Olaparib (Qipani).®), and produced two specifications: 100mg and 150mg. In the bioequivalence analysis, Qilu Olaparib has pharmacokinetic characteristics similar to the original Olaparib, with similar dissolution behavior, absorption rate, and extent of absorption.

The official launch of Qilu Olaparib will provide a cost-effective new treatment option with similar quality and accessibility to the original Olaparib, benefiting a wide range of ovarian cancer patients in China. This will reduce the financial burden on ovarian cancer patients, helping more patients complete full courses of treatment and achieve sustained survival benefits. It is anticipated that Qilu Olaparib can be applied to more ovarian cancer patients in the future, bringing good news to even more patients!