Pharmaceutical Market Europe • May 2025 • 8-9
NEWS
AstraZeneca/Daiichi Sankyo’s Enhertu shows promise in phase 3 study
AstraZeneca (AZ) and Daiichi Sankyo have shared promising results from a late-stage study of their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-positive metastatic breast cancer.
The phase 3 DESTINY-Breast09 study has been evaluating the drug in combination with pertuzumab as a first-line treatment for this patient population.
Up to 20% of those with metastatic breast cancer are affected by HER2-positive disease. Despite HER2-targeted therapies improving outcomes, the majority of patients experience disease progression within two years of first-line treatment with standard-of-care taxane, trastuzumab and pertuzumab (THP).
Enhertu plus pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival compared to THP, with this benefit seen across all pre-specified patient subgroups.
Interim overall survival data also showed an early trend favouring Enhertu plus pertuzumab compared to THP, but this was not mature at the time of the planned interim analysis.
The results make DESTINY-Breast09 the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic breast cancer patient population compared to THP, according to the companies.
Gilead shares positive results for Trodelvy/Keytruda combination
Gilead Sciences has announced positive top-line results from a late-stage study evaluating its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) with Merck & Co’s anti-PD-1 therapy Keytruda (pembrolizumab) in triple-negative breast cancer (TNBC) patients.
The phase 3 ASCENT-04/KEYNOTE-D19 trial met its primary endpoint, with the combination significantly improving progression-free survival compared to Keytruda and chemotherapy in patients with unresectable locally advanced or metastatic TNBC whose tumours express PD-L1.
There was also an early trend in improvement for overall survival, the study’s secondary endpoint, with Trodelvy plus Keytruda, but this data was not mature at the time of analysis and will continue to be monitored.
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat. Patients are at an increased risk of recurrence and metastases compared to those with other breast cancer types and, despite advances in treatment, first-line metastatic TNBC has seen limited approvals in recent years for tumours expressing PD-L1.
Gilead and Merck – known as MSD outside the US and Canada – entered into a collaboration in 2021 to investigate the Trodelvy/Keytruda combination in ASCENT-04/KEYNOTE-D19.
Ipsen’s elafibranor shows potential in rare liver disease
Ipsen’s elafibranor has shown promise as a treatment for primary sclerosing cholangitis (PSC), a rare liver disease that currently has no approved treatment options.
Results from the phase 2 ELMWOOD study, which has been comparing two doses of the drug against placebo in 68 PSC patients, were presented at this year’s European Association for the Study of the Liver congress.
PSC is characterised by inflammation and scarring of the bile ducts, which can result in liver damage and eventually liver failure.
Data from ELMWOOD demonstrated a positive safety and tolerability profile, the trial’s primary endpoint, for elafibranor-treated patients versus those receiving placebo.
Patients on elafibranor experienced significant dose-dependent reductions in alkaline phosphatase at week 12 compared to placebo, with improvements seen from week four.
Similar results were demonstrated in other biochemical liver parameters, including alanine aminotransferase and gamma-glutamyl transferase, two key biochemical markers of disease progression.
Additionally, elafibranor was associated with stabilisation in enhanced liver fibrosis compared to placebo at week 12, and patients receiving a 120mg dose of Ipsen’s drug experienced improvements in itch compared to those on placebo.
Roche commits $50bn to boost US footprint
Roche has announced a significant investment in the US, committing $50bn into the country over the next five years.
The investment is aimed at bolstering the company’s pharmaceutical and diagnostics divisions, and is expected to create more than 12,000 new jobs, including 1,000 at Roche and over 11,000 “in support of new US manufacturing capabilities”.
The funds will go towards building a new 900,000 square foot manufacturing centre at a yet-to-be announced location to support Roche’s expanding portfolio of weight loss drugs, as well as establishing a gene therapy manufacturing facility in Pennsylvania and a manufacturing facility for continuous glucose monitoring in Indiana.
The investment is also set to cover a new centre in Massachusetts that will serve as a hub for the company’s new cardiovascular, renal and metabolism research and development (R&D) efforts.
Alongside the new sites, Roche said it will use the investment to expand and upgrade its manufacturing and distribution capabilities for its medicines and diagnostics portfolio in Kentucky, Indiana, New Jersey, Oregon and California, as well as its existing pharmaceuticals and diagnostics R&D centres in Arizona, Indiana and California.
Novartis invests $23bn into US-based infrastructure
Novartis has unveiled plans to invest $23bn into its US-based infrastructure over the next five years, allowing it to produce 100% of its key medicines end-to-end in the country.
The investment will go towards establishing a $1.1bn biomedical research innovation hub in San Diego, California, building two new radioligand therapy manufacturing facilities in Florida and Texas, as well as expanding three existing radioligand therapy manufacturing facilities in Indiana, New Jersey and California.
The funds also cover four new manufacturing facilities in “soon-to-be-determined” states. Three of these will focus on producing biologics drug substances, drug products, device assembly and packaging, while the other will make chemical drug substances, oral solids dosage forms and packaging.
Novartis said it already manufactures its “most innovative, advanced therapies” in the US for patients in the country and globally.
The company expects the new investment will provide it with manufacturing capacity for all of its core technology platforms, including small molecules and biologics, and will bring internal manufacturing of its small interfering RNA technology to the country for the first time.
UK AMR study highlights importance of proper antibiotic use
The UK Health Security Agency (UKHSA) has found that some bacteria have already developed resistance to ceftazidime/avibactam, an antibiotic that was only introduced to the NHS in 2017.
Despite levels of resistance to ceftazidime/avibactam being low, the government agency said the findings from its study are an “important reminder” to ensure that antibiotics are used appropriately.
Responsible for an estimated 1.27 million deaths globally in 2019, antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and find ways to resist the effects of antimicrobial drugs. Although AMR occurs naturally, the use of antibiotics accelerates the process.
Ceftazidime/avibactam is used to treat serious infections in hospitals, usually after other antibiotics have failed or in patients who are infected with known multi-drug resistant bacteria. It is classed as a ‘reserve’ antibiotic, meaning it should be prescribed only in exceptional circumstances.
After analysing data from 2016 to 2020, the UKHSA found that 6.3% of bacteria tested in routine surveillance showed resistance to ceftazidime/avibactam. Percentage resistance per bacterial species was shown to vary over time and stabilised as routine surveillance testing was established.
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