After withdrawal, GSK’s Blenrep shows promise in phase 3 DREAMM-7 study

In November 2022, GSK began the process of withdrawing Blenrep’s U.S. marketing authorization after the phase 3 DREAMM-3 trial failed to show an overall survival benefit compared to standard therapy. But GSK has signaled its hope that the B-cell maturation antigen (BCMA) antibody-drug conjugate could have a new lease on life with new data from the phase 3 DREAMM-7 study.

Blenrep shows promise in DREAMM-7 study as combination therapy

The study revealed that combining Blenrep (belantamab mafodotin) with the proteasome inhibitor bortezomib and the steroid dexamethasone (BorDex) improved progression-free survival by 59% compared to a combination of Darzalex (daratumumab) and BorDex. Additionally, progression-free survival was extended to 36.6 months with Blenrep plus BorDex, versus only 13.4 months with the daratumumab regimen. Finally, the DREAMM-3 study found an early but strong and clinically meaningful trend toward improved overall survival favoring the Blenrep …

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Pharma giants make progress in pivot to mRNA technology in race for next-gen influenza vaccines, but hurdles remain

[Image courtesy of Adobe Stock]

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But with demand for COVID-19 vaccines cooling, drug developers are aiming to extend the dominion of mRNA technology to flu vaccines. This month, Moderna and the CureVac/GSK alliance announced promising interim results for their respective flu vaccine candidates. Meanwhile, a year ago, in September 2022, Pfizer announced a phase 3 study for its mRNA-based influenza vaccine. NIH is also developing an mRNA vaccine that promises to provide protection against all known influenza subtypes. A phase 1 study of it is underway.

Sanofi has acknowledged the promise and perils of mRNA flu vaccines

Sanofi, a prominent flu vaccine maker, has acknowledge…

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Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine

Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now highlights as the first FDA-approved maternal vaccine to guard infants against RSV.

In early May, GSK’s Arexvy became the first to win FDA’s blessing to protect individuals aged 60 and above from RSV complications. By the end of the month, Pfizer had won approval for Abrysvo in the same age group.  

Yet, behind the scenes of these approvals, legal clouds gather. GSK has taken its grievances to a federal court in Delaware, alleging that Pfizer infringed on four of its patents related to its Arexvy vaccine. In a Reuters-posted filing, GSK claims it began work on its  RSVPreF antigen in the early 2000s. In th…

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An overview of the RSV vaccine landscape: What comes after GSK’s approval of Arexvy?

[Peter Hansen/Adobe Stock]

GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations.

The GSK vaccine targets adults aged 60 and older. In clinical studies, the single-dose vaccine demonstrated strong efficacy in preventing lower-respiratory tract infections and more severe diseases. In a phase 3 study published in NEJM with a median follow-up of 6.7 months, the vaccine efficacy against RT-PCR-confirmed RSV-related lower respiratory tract disease was 82.6%.

Efficacy against severe RSV-related lower respiratory tract disease was higher at 94.1% while efficacy against RSV-related acute respiratory infection was 71.7%. The most commonly reported side effects of Arexv…

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An overview of the RSV vaccine candidate landscape in early 2023

[RSV image from NIAID]

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk.

Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956. A year later, the pediatrician and virologist Robert M. Chanock linked RSV to respiratory infections in children. Attempts to develop a vaccine for the virus soon followed.

Despite numerous attempts beginning in the 1960s, an FDA-approved RSV vaccine has remained elusive until recently. Out front is GSK’s (NYSE:GSK) RSV vaccine for adults aged 60 and older, which has won the backing of an FDA advisory panel. Close behind is Pfizer’s (NYSE:PFE) single-dose vaccine for the same a…

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GSK announces plans for new headquarters in London

GSK plc (LSE/NYSE:GSK) has announced its plans to move to its global headquarters to a new building in central London in 2024.

The company is currently based in Brentford, a suburban town in West London.

GSK isn’t the only Big Pharma company to announce a headquarters change. In late November, Sanofi (Nasdaq:SNY) moved its home base to Paris’s 17th arrondissement neighborhood.

The company terms its new six-storied headquarters as the ‘Earnshaw.’

Approximately 3,000 employees will be based at the site. It will have offices for the company’s C-suite. It will also have space for the company’s R&D team, and employees focused on the supply chain, operations, corporate functions and HIV-focused ViiV Healthcare, a joint venture with Pfizer and Shionogi.

The headquarters will be a hybrid working environment.

Construction of the Earnshaw building is slated for completion in 2023.

GSK spun out its consumer division, which it branded…

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Europe approves GSK and Sanofi’s next-gen COVID-19 booster vaccine VidPrevtyn Beta

The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18.

The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval.

Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant.

After announcing the news, Sanofi shares were up 1.45% to $43.97 in early afternoon trading. GSK shares were up 2.42% to $33.21.

VidPrevtyn Beta is a monovalent, recombinant-protein vaccine developed by Sanofi, modeled on the Beta variant and including GSK’s pandemic adjuvant. The vaccine uses recombinant-protein technology found in Sanofi’s seasonal flu vaccines.

In July, GSK and Sanofi announced that their adjuvanted bivalent version of its vaccine was 72% efficacious against omicron in adults in a Phase 3 study.

GSK and Sanofi noted that the vaccine performed well in registrational trials when the omi…

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GSK stops two Phase 3 studies for novel antibiotic gepotidacin stopped early

GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee.

Gepotidacin is a topoisomerase type II inhibitor.

The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3 studies, involving data from more than 3,000 patients, sought to establish non-inferiority to nitrofurantoin for uncomplicated urinary tract infections (uUTIs).

EAGLE-2 and EAGLE-3 provided a test-of-cure (TOC) visit for gepotidacin compared with the traditional antibiotic nitrofurantoin in patients with a uUTI. Patients in the study were confirmed to have a uropathogen sensitive to nitrofurantoin. The data monitoring committee did not note any safety concerns.

GSK is gearing up a New Drug Application for gepotidacin, which it intends to file in the first hal…

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GSK’s RSV vaccine candidate for older adults wins priority review from FDA 

On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults.

The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA) review time.

The PDUFA date for the vaccine candidate is May 3, 2023.

Several other companies are also developing RSV vaccines, including Pfizer (NYSE:PFE), Icosavax (Nasdaq:ICVX) and Moderna (Nasdaq:MRNA).

GSK said that its RSV vaccine, if approved, would be the first to protect adults 60 and over from RSV infections, which can lead to pneumonia, hospitalization and death.

While researchers have sought to develop RSV vaccines since the 1960s, no vaccine against the virus is currently available.

In granting the BLA, FDA reviewed data from a prespecified interim analy…

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GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer

[Image courtesy of GSK]

GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients.

The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy. A blinded independent central review evaluated the study’s results with RECIST v1.1 criteria.

AnaptysBio (Nasdaq:ANAB), a clinical-stage biotech, originally developed dostarlimab, which it later licensed to Tesaro, which GSK acquired in early 2019.

The randomized, double-blind PERLA study enrolled 243 patients.

GSK notes that the trial is the most extensive global head-to-head study of programmed death receptor-1 (PD-1) inhibitors in patients with metastatic non-squamou…

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Niraparib promoted long-term progression-free survival benefit in Phase 3 advanced ovarian cancer study 

Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients.

The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp.

Patients in the HRd subgroup had a 48% reduction of progression or death compared to placebo.

The estimated probability of no progressive disease or death at four years in the broader population was 24% for niraparib compared to 14% for placebo.

GSK plans to present the updated efficacy analysis data on September 11 at the (European Society for Medical Oncology) ESMO Annual Meeting in Paris.

GSK noted in a news release that the overall survival data are “not yet mature based on the prespecified analysis plan.”

The study tested niraparib as maintenance therapy in first-line ovarian…

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WHO decision clears path for GSK’s Mosquirix malaria vaccine

The World Health Organization (WHO) has awarded prequalification to GSK’s (LSE/NYSE:GSK) Mosquirix.

The move marks the first time that a malaria vaccine has won prequalification.

The WHO decision regarding the Mosquirix malaria vaccine is a prerequisite for United Nations (UN) agencies like UNICEF to procure the vaccine in regions with moderate to high P. falciparum malaria transmission.

Malaria was associated with 409,000 deaths in 2019, according to WHO.

GSK shares fell 1.19% in afternoon trading to $31.47.

The Mosquirix malaria vaccine is also referred to as RTS and S/AS01.

Mosquirix has a long developmental history. GSK began developing the vaccine, then known as RTS,S, in 1987.

In 2001, GSK and PATH’s Malaria Vaccine Initiative entered into a public-private partnership to develop the vaccine for infants and young children in malaria-prone countries.

To win the WHO prequalification, GSK shared detailed c…

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