Novartis Releases New Clinical Data for Mayzent in SPMS; AbbVie’s Imbruvica Receives 11th FDA Approval

Roche Releases Q1 Financial Results

Today, Roche announced its first-quarter financial results. In Q1 2020, the company’s sales increased by 2% in Swiss francs and by 7% at constant exchange rates, reaching CHF 15.1 billion. Sales in the Pharmaceuticals division rose by 7% to CHF 12.3 billion, with notable growth driven particularly by four drugs: Tecentriq, Hemlibra, Ocrevus, and Perjeta. Despite the impact of biosimilar competition during the COVID-19 pandemic, Roche delivered a reasonably strong performance.

In the first quarter, Tecentriq received its first approval in China for use in combination with chemotherapy for the treatment of patients with extensive-stage small cell lung cancer; it also obtained two approvals in the European Union: one for the antibody-drug conjugate Polivy in combination with bendamustine and Rituxan for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior therapies, and another for Venclyxto (venetoclax) in combination with Gazyvaro (obinutuzumab) for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL).

Roche believes that the fluctuating impact of the COVID-19 pandemic on certain markets had a limited effect on its first-quarter operating performance. Based on the current assessment of the impact of COVID-19, the company’s 2020 outlook has been established, with sales expected to grow in the low-to-mid single-digit range at constant exchange rates.

Gilead and oNKo-innate Collaborate on the Development of NK Cell Therapy

On April 21 local time, Kite Pharma, a subsidiary of Gilead Sciences, and the biotechnology company oNKo-innate announced that they had launched a three-year research collaboration in cancer immunotherapy to support the discovery and development of next-generation drugs and cell therapies focused on natural killer (NK) cells.

Current cancer immunotherapy approaches primarily focus on T cell-mediated anti-tumor immunity, including immune checkpoint inhibition and chimeric antigen receptor (CAR) T-cell therapy. Like T cells, natural killer (NK) cells are a subset of lymphocytes (white blood cells) that play critical roles in immune surveillance and effector functions. While both NK cells and T cells possess the potential to target cancer cells, they employ distinct mechanisms for killing tumor cells. Therefore, appropriately activated and targeted NK cells may represent a differentiated therapeutic approach, potentially complementary and synergistic with T cell-mediated anti-tumor therapies.

Through this research collaboration, oNKo-innate will leverage whole-genome screening technology and its proprietary technology platform to discover new immune cell targets, enhance NK cell anti-tumor immunity, and develop NK cell therapies. oNKo-innate will help Gilead launch an immuno-oncology discovery program.

Novartis Announces Latest Clinical Data for Mayzent

On April 21 local time, Novartis published the latest data on Mayzent in *Neurology*, the medical journal of the American Academy of Neurology. Building upon existing clinical data, these findings demonstrate that Mayzent can slow the progression of limb paralysis and provide cognitive benefits for patients with secondary progressive multiple sclerosis (SPMS).

Long-term efficacy and safety of Mayzent in patients with SPMS were evaluated based on the published five-year extension trial data, in which some patients continued Mayzent treatment (experimental group) while others switched from placebo to Mayzent (placebo-switch group). Compared with the placebo-switch group, patients in the experimental group had a significantly lower likelihood of confirmed disability progression (CDP) at three and six months, highlighting the benefits of early treatment. The new data also showed that the annualized relapse rate (ARR) was reduced by 52% in the experimental group compared with the placebo control group (p<0.0001). Compared with the placebo-switch group, the experimental group demonstrated a 23% reduction in the risk of confirmed worsening of cognitive impairment at six months (p=0.0014).

Imbruvica’s 11th Indication Approved by the FDA

On April 21 local time, AbbVie announced that the U.S. Food and Drug Administration (FDA) had approved the combination of Imbruvica (ibrutinib) and rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This marks the 11th indication approved for Imbruvica since its launch in 2013, including six approvals in the CLL indication.

Brian Koffman, Chief Medical Officer and Executive Vice President of the CLL Society, stated, “For many patients with chronic lymphocytic leukemia (CLL), intravenous chemotherapy has long been the gold standard first-line clinical treatment; however, many patients are unable to tolerate chemotherapy regimens. The FDA approval of the Imbruvica plus rituximab regimen is undoubtedly welcome news for patients seeking non-chemotherapy first-line treatment options. This will also drive a shift in the clinical management of younger CLL patients.”

The FDA’s approval was primarily based on the results of the Phase III E1912 study of Imbruvica. The agency expedited the review process through various pathways, including Real-Time Oncology Review (RTOR), Priority Review, and the Orbis Project. The E1912 study enrolled 529 previously untreated patients with chronic lymphocytic leukemia (CLL) under 70 years of age (median age: 58 years), who were randomized in a 2:1 ratio to receive either Imbruvica plus rituximab (n=354) or fludarabine plus cyclophosphamide plus rituximab (FCR; n=175). The results demonstrated that Imbruvica plus rituximab significantly prolonged progression-free survival (PFS) compared with the FCR regimen.

Biogen Releases Corporate Social Responsibility Report

Recently, Biogen released its 2019 Corporate Social Responsibility Report, highlighting progress across several environmental, social, and governance (ESG) metrics. The report outlines the company’s long-term commitment to corporate social responsibility by adopting a multi-stakeholder approach in business decisions, fostering an inclusive culture, reducing environmental pollution, and enhancing ESG performance.

In 2019, Biogen achieved an absolute reduction of nearly 3% in water usage, 7% in hazardous and non-hazardous waste, 3% in supply chain emissions, and 1.6% in non-renewable energy consumption, while its total annual revenue increased by 7% compared to the previous year.

Additionally, during the COVID-19 pandemic, the Biogen Foundation pledged a $10 million donation to support COVID-19 prevention and control efforts. Several nonprofit organizations and health systems promptly received support from the Biogen Foundation. Biogen employees also contributed more than $300,000 in donations to nonprofit organizations and were encouraged to participate in volunteer work.

Reference Sources:

1、Gilead, Kite and oNKo-innate Announce Research Collaboration to Discover Cancer Immunotherapies Focused on Natural Killer (NK) Cells

2、IMBRUVICA® (ibrutinib) Receives 11th FDA Approval

3、Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS)

4、BIOGEN RELEASES 2019 CORPORATE RESPONSIBILITY REPORT DEMONSTRATING CONTINUOUS PROGRESS ACROSS ENVIRONMENTAL, SOCIAL AND GOVERNANCE METRICS

5、First quarter with 2% growth in Swiss francs, 7% at constant exchange rates

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