Swiss pharma company Roche has entered into a definitive merger agreement to acquire GenMark Diagnostics for approximately $1.8bn.

Roche has seen its diagnostics division grow during the pandemic, having received a number of emergency use authorisations from the US Food and Drug Administration (FDA) for its COVID-19 tests.
As part of its proposed acquisition of GenMark, Roche will add the company’s respiratory pathogen panels to its arsenal.
This diagnostic identifies the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2, which causes COVID-19.
Roche is offering to fully acquire GenMark for $24.05 per share, reflecting a total transaction value of approximately $1.8bn. The deal has been approved by both Roche and GenMark’s boards of directors and is expected to close in the second quarter of the year.
“As a part of Roche, we can accelerate our mission to enable rapid diagnosis of infectious disease to improve patient outcomes. Together with Roche’s diagnostics healthcare solutions, we will be able to provide a full suite of molecular diagnostic solutions to customers around the world,” said Scott Mendel, chief executive officer of GenMark.
“We are thrilled to become part of Roche and are confident that this is the right path forward for GenMark and our customers,” he added.

The European Medicines Agency (EMA) has begun an accelerated review of Gilead’s Trodelvy for the treatment of advanced triple-negative breast cancer.

Gilead is seeking an EU authorisation for Trodelvy (sacituzumab govitecan-hziy) for the treatment of unresectable locally advanced or metastatic TNBC patients who have received at least two prior therapies.

Trodelvy, which Gilead acquired as part of its $21bn buyout of Immunomedics, is an antibody-drug conjugate (ADC) targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumours including TNBC.

TNBC is a particularly aggressive type of cancer, and high expression of Trop-2 in particular is associated with poor survival and relapse.

The ADC was approved by the US Food and Drug Administration (FDA) in April last year for the treatment of metastatic TNBC.

That approval was supported by results from the phase 3 ASCENT study of Trodelvy in metastatic TNBC patients in the later stages of the treatment pathway.

Patients who received Trodelvy in this study had a median progression-free survival of 5.6 months, compared to 1.7 months for those who received chemotherapy alone.

For overall survival, the median rate for those treated with Trodelvy was 12.1 months versus 6.7 months in the chemotherapy group, with the results also showing that more cancers responded to Trodelvy compared to chemotherapy.

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s BCMA-targeting CAR T-cell therapy Abecma – previously known as ide-cel – for the treatment of multiple myeloma.

The FDA has authorised Abecma for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, such as Janssen’s Darzalex (daratumumab).

In September 2020, the FDA granted the CAR T-cell therapy a priority review, after initially issuing a refuse-to-file letter in May 2020.

In its letter, the FDA asked BMS and bluebird bio for additional data before the agency processed and reviewed the submission.

Following this, BMS and bluebird bio refiled the biologics licence application, saying that the new application provided further details about the chemistry, manufacturing and control (CMC) module of the submission to address the FDA’s initial concerns.

The eventual approval is based on results from the phase 2 KarMMa study of ide-cel.
This evaluated the therapy of three doses in 128 patients who had received on average six previous therapies.

In this heavily pretreated group, ide-cel induced an overall response rate of 81.5% and a complete response rate of 35.2%.

Remissions in the study lasted an average of 10.6 months, and median progression-free survival reached 8.6 months.

Eli Lilly has revealed expanded findings from a phase 2 trial of its potential Alzheimer’s disease treatment donanemab, and announced plans to expand the clinical programme for the drug in a bid for regulatory approval.

In January, top-line data from the TRAILBLAZER-ALZ trial in patients with early symptomatic Alzheimer’s showed that donanemab slowed cognitive decline by 32% on the Integrated Alzheimer’s Disease Rating Scale (iARDS) compared to placebo.

Although newly reported findings for secondary outcomes within this trial ‘showed no substantial difference’, Lilly highlighted exploratory analyses that showed donanemab slowed the accumulation of tau across key brain regions in Alzheimer’s patients.

The researchers identified improvement in scores on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item cognitive subscale of the AD Assessment Scale (ADAS-Cog13), although this did not translate to statistical significance between the donanemab-treated and placebo groups.

In addition, 40% of donanemab-treated patients achieved amyloid negativity as early as six months after starting treatment and 68% achieved this target by 18 months.

Lilly announced that it would enrol another 1,000 participants into an expanded trial – TRAILBLAZER-ALZ 2 – to confirm the efficacy and safety of donanemab in a larger population of Alzheimer’s patients.

The company is expecting to complete enrolment of additional participants later this year, with data from this trial anticipated in early 2023.