ovarian cancer

NICE has given its recommendation for the routine use on the NHS in England and Wales of AstraZeneca and MSD’s Lynparza (olaparib) for the maintenance treatment of relapsed, advanced, BRCA+ ovarian cancer, it has been announced, making the drug available to all BRCA-mutated patients.

Specifically, this new ruling affects adult NHS patients who are living with relapsed, platinum-sensitive high grade epithelial ovarian, fallopian tube or peritoneal cancer with the BRCA1 or BRCA2 mutation (BRCAm) which has responded to platinum-based chemotherapy.

New research from GlobalData has forecast that the worldwide market for ovarian cancer is set to expand at a compound annual growth rate (CAGR) of 14.4% from its 2018 valuation of $1.8 billion to reach $6.7 billion by 2028.

This growth is predicted to be driven predominantly by adoption of maintenance therapy for the disease across the US, UK, France, Germany, Spain, Italy and Japan.

NICE has announced it has made an about-face on its earlier ruling for Clovis Oncology’s Rubraca (rucaparib), revealing that the drug will now be made available immediately via the Cancer Drugs Fund (CDF) for women in England with relapsed ovarian, fallopian tube or peritoneal cancer, that has responded to platinum-based chemotherapy.

The UK watchdog originally turned down the therapy due to concerns over the certainty of the data submitted, as well as over cost-effectiveness, based on the price put forward by Clovis.

At the 2019 European Society for Medical Oncology (ESMO) congress, GlaxoSmithKline unveiled new Phase 3 data on Zejula (niraparib) for the maintenance of first-line ovarian cancer that has responded to platinum-based chemotherapy.

The data revealed that the drug improved progression-free survival (PFS) by 38% in the overall population of the PRIMA study. Within sub-populations of this overall group, the drug was found to improve PFS by 60% in BRCA mutation tumours, 50% in HR-deficient BRCA wild type tumours, and 32% in HR-proficient tumours

New Phase 3 data has emerged on AstraZeneca and MSD’s Lynparza (olaparib), showing that the PARP inhibitor achieved its primary endpoint in the first-line maintenance of advanced ovarian cancer in patients with or without BRCA mutations when added to standard-of-care bevacizumab, compared to bevacizumab alone.

The companies declared that the drug combo was found to produce a £statistically-significant and clinically-meaningful improvement in progression-free survival (PFS)”, marking the second positive set of results for Lynparza in first-line ovarian cancer.

AstraZeneca and MSD’s jointly-developed therapy Lynparza (olaparib) has scored its third EU approval, the pair announced, with authorisation for the first-line treatment of female patients with BRCA-mutated advanced ovarian cancer.

Specifically, the authorisation covers the maintenance of FIGO Stages III and IV BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in those who are in response (complete or partial) following completion of 1st-line platinum-based chemotherapy.

Shares in ImmunoGen fell 32% in premarket trading after the firm said the FDA had recommended a new Phase 3 trial of its ovarian cancer drug mirvetuximab soravtansine.

The experimental antibody-drug conjugate (ADC) mirvetuximab soravtansine is being trialled in patients with high folate receptor (FR) alpha-positive, platinum-resistant ovarian cancer.

In March, Massachusetts-based biotech ImmunoGen reported that its 366 patient FORWARD I trial had failed to meet its primary endpoint of progression free survival.

AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged, as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

Specifically, the recommendation covers the use of the drug as a maintenance treatment for adult patients advanced BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Pfizer and Merck KGaA have chosen to discontinue the Phase 3 JAVELIN trial looking into avelumab in combination with chemotherapy as a treatment for advanced ovarian cancer.

The discontinued trial sought to investigate avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV).

British multinational GlaxoSmithKline (GSK) have acquired US oncology firm Tesaro for $5.1 billion (£4 billion).

Tesaro, a Massachusetts-based clinical stage biopharmaceutical company, won approval for ovarian cancer drug Zejula in March 2017. Zejula, an oral poly ADP ribose polymerase (PARP) inhibitor, is currently approved in the US and Europe for adults with recurrent ovarian cancer.