BeiGene Submits Zanidatamab for Approval; AbbVie Reports Positive Elahere Data; GSK’s RSV Vaccine Arexvy Receives FDA Label Expansion

Jun 10, 2024 12:05 CST Updated 12:05

BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

GSK

Pharmaceutical R&D Manufacturer

BeOne Medicines' HER2 Bispecific Antibody Zanidatamab Submitted for Market Approval

On June 7, the CDE website showed that BeOne Medicines' HER2 bispecific antibody zanidatamab had its marketing application accepted. In November 2023, the product was granted priority review for the treatment of patients with unresectable locally advanced or metastatic biliary tract cancer exhibiting high HER2 expression who have previously received systemic therapy.

Zenidatamab is a novel HER2-targeted bispecific antibody. Compared with trastuzumab, zenidatamab exhibits enhanced antitumor activity both in vitro and in vivo across different HER2-overexpressing tumor cell types and varying levels of HER2 expression. Results from human cell lines and animal models suggest that zenidatamab may also possess clinical activity against tumors with low HER2 expression.

In June 2023, BeOne Medicines presented the results of the Phase IIb HERIZON-BTC-01 study at the ASCO conference. This was an open-label, global Phase IIb study that enrolled 87 patients with HER2-amplified locally advanced unresectable or metastatic biliary tract cancer who had previously received gemcitabine-based treatment. The primary endpoint was the centrally confirmed objective response rate (cORR) by independent central review (ICR) in the HER2-positive cohort, with secondary endpoints including other efficacy and safety data.

The results showed that, in HER2-positive patients, the cORR was 41%, the median duration of response (DOR) was 12.9 months, and the median study follow-up time was 12.4 months. As of October 10, 2022, among the 33 responders, 49% had a sustained response and 82% had a DOR ≥16 weeks. The median time to first response was 1.8 months.

In terms of safety, 72% of patients experienced treatment-related adverse events (TRAEs); TRAEs occurring in ≥10% of patients were diarrhea (37%) and infusion-related reactions (33%). Grade 3 TRAEs occurred in 18% of patients. Two patients discontinued zanidatamab due to adverse events, and seven patients experienced serious TRAEs.

At this year's ASCO conference, the study unveiled overall survival (OS) data for the first time. Long-term follow-up results showed that the median OS of patients in the zanidatamab treatment group reached 15.5 months. Currently, the FDA has accepted the Biologics License Application (BLA) for zanidatamab and granted it priority review status, with a PDUFA date set for November 29, 2024.

AbbVie's ADC Product Elahere Announces Positive Clinical Data

Recently, AbbVie announced positive results from the Phase 2 clinical trial PICCOLO, which evaluated its "first-in-class" antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) as a monotherapy for the treatment of folate receptor alpha (FRα)-positive platinum-sensitive ovarian cancer (PSOC) patients who had previously received extensive treatment. Analysis showed that the trial met its primary endpoint, with an objective response rate (ORR) reaching 51.9%.

PICCOLO is a single-arm phase 2 trial designed to evaluate the efficacy and safety of Elahere monotherapy in FRα-positive PSOC patients who have previously received at least two platinum-based regimens. The primary endpoint is ORR, and the key secondary endpoint is duration of response (DOR).

Analysis showed that the study met its primary endpoint, with an ORR of 51.9% (95% CI: 40.4–63.3) in patients. Additionally, the median Duration of Response (DOR) was 8.25 months, a key secondary endpoint of the trial. The safety profile of Elahere was consistent with findings from previous studies, with no new safety signals identified.

Elahere is also being studied in the Phase 3 GLORIOSA trial, which aims to evaluate the combination of Elahere and bevacizumab compared to bevacizumab alone as maintenance therapy in PSOC patients after receiving platinum-based doublet second-line treatment.

GSK RSV Vaccine Receives FDA Approval for Expanded Age Range

On June 7, GSK announced that the FDA approved the expanded use of the recombinant Respiratory Syncytial Virus (RSV) vaccine Arexvy to include high-risk adults aged 50-59. This is the first RSV vaccine to protect high-risk individuals aged 50-59.

Arexvy was approved for marketing in the United States and Europe in 2023, respectively, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and above. As the world's first marketed RSV vaccine, Arexvy has performed quite well in sales, generating revenue of £1.238 billion (approximately $1.545 billion) within just nine months of its launch, quickly earning a spot on the list of "blockbuster" drugs.

The expansion of the eligible population is based on positive results from a Phase III placebo-controlled, randomized study (NCT05590403). The trial aimed to evaluate the non-inferiority and safety of immune responses in participants aged 50-59 with an increased risk of RSV-LRTD compared to elderly individuals aged 60 and above after a single dose of Arexvy.

The results showed that the immune response in the 50-59 age group was non-inferior to that in the 60 and above age group, reaching the primary endpoint. In addition, the study also achieved secondary and tertiary endpoints for safety and immunogenicity.

In the RSV vaccine race, in addition to GSK's Arexvy and Pfizer's Abrysvo being successively approved for marketing last year, Moderna's RSV vaccine mRESVIA has also been recently approved for marketing a year later, joining the competition in the RSV vaccine field.

Editor：yc