Clinical Research

Transgene lung cancer drug fails

Country
France

A combination therapy directed at patients with advanced non-squamous non-small cell lung cancer, failed to show a clinically meaningful overall response rate in a Phase 2 clinical trial, the developer Transgene SA announced on 12 December. Transgene has stopped further development of the compound TG4010, which is a cancer vaccine based on a modified Vaccinia virus.

Positive data for GSK antibody-drug conjugate

Country
United Kingdom

The antibody-drug conjugate belantamab mafodotin has generated an overall response rate of 31% in a pivotal Phase 2 study of patients with relapsed/refractory multiple myeloma, GlaxoSmithKline Plc announced on 17 December. The UK company has made a regulatory submission for the drug with the US Food and Drug Administration.

Novartis to discontinue fevipiprant in asthma

Country
Switzerland

Novartis is to discontinue development of the small molecule drug fevipiprant as a treatment for asthma following the failure of two Phase 3 studies to show a reduction in the rate of moderate-to-severe exacerbation compared with placebo. A pooled analysis of the LUSTER-1 and LUSTER-2 studies did not meet the clinical threshold of efficacy for either of the two doses of the drug over a period of 52 weeks.

“The totality of these results do not support further development of fevipiprant in asthma,” the company said in a statement on 16 December.

New long-term data for Yescarta

Country
United States

New long-term data for the cancer therapy Yescarta (axicabtagene ciloleucel) have shown that nearly half of patients treated with the cell-based gene therapy were alive three years after treatment. The long-term data were presented on 7 December at the American Society of Hematology meeting in the US, and are similar to outcome data reported in 2017.

Tecentriq with Avastin improves survival in liver cancer

Country
Switzerland

The checkpoint antibody Tecentriq (atezolizumab), when combined with Avastin, has shown  statistically significant and clinically meaningful improvements in overall survival and progression-free survival in patients with unresectable hepatocellular carcinoma, the most common type of primary liver cancer, Roche announced on 22 November. The Phase 3, 501-patient trial compared the combination therapy with sorafenib, the standard of care for advanced liver cancer.

Cosentyx narrowly misses superiority

Country
Switzerland

The immunosuppressant Cosentyx (secukinumab) narrowly missed statistical significance for superiority in a head-to-head trial against Humira in patients with active psoriatic arthritis, Novartis announced on 1 November. The 52-week trial, called EXCEED, evaluated the two drugs in more than 800 patients who were naïve to a biologic therapy.

Second Ebola vaccine to be tested in DRC

Country
Denmark

A second experimental Ebola vaccine is to be tested in a large clinical trial in the Democratic Republic of Congo (DRC) as public health authorities mobilise resources to contain an outbreak of Ebola virus disease, declared by the World Health Organization to be a public health emergency.

MorphoSys buoyed by real-world study

Country
Germany

Like many developers of cancer drugs, MorphoSys AG is using data from a single-arm Phase 2 trial as the basis for a regulatory submission to the US Food and Drug Administration. The company’s L-MIND trial reported positive results in May showing that the antibody tafasitamab, combined with the myeloma drug lenalidomide, met its primary endpoint of objective response in patients with lymphoma. This is the basis of a rolling submission to the FDA.

GSK reports positive results from TB trial

Country
United Kingdom

A vaccine designed to reduce the incidence of pulmonary tuberculosis in HIV-negative adults has shown an overall efficacy rate of 50%, according to the developers GlaxoSmithKline Plc and the international AIDS vaccine initiative (IAVI). The Phase 2b study enrolled adults with latent TB infection, which is estimated to affect one-quarter of the global population. Of this number, an estimated 10% will develop active pulmonary TB disease.

Tucatinib meets PFS endpoint in breast cancer

Country
United States

The kinase inhibitor tucatinib has shown a 46% reduction in the risk of breast cancer progression in a Phase 3 trial that enrolled patients who had previously received two antibody treatments and one antibody-drug conjugate. Announcing the results on 21 October, Seattle Genetics Inc said a US regulatory filing is planned for the first quarter of 2020.