Whole-cell vaccine and checkpoint inhibitor improve survival in breast cancer patients
A survival rate of 82% and a disease control rate of 64% were reported in 11 subjects with advanced metastatic breast cancer enrolled in a Phase 2 trial testing a combination of cell vaccine Bria-IMT (BriaCell) and the PD-1 inhibitor retifanlimab (Incyte).
Bria-IMT is a genetically engineered, allogeneic cell line expressing the breast cancer antigen HER2/neu and the immunostimulant GM-CSF.
mRNA-based personalized cancer vaccine receives breakthrough designation for melanoma
The US Food and Drug Administration (FDA) has granted its breakthrough therapy designation to a combination regimen consisting of a personalized mRNA cancer vaccine mRNA-4157/V940 (Moderna) and the PD-1 inhibitor pembrolizumab (Keytruda, Merck) as adjuvant treatment of high-risk melanoma following surgical resection. The decision is based on Phase 2 data showing that the combination provided a survival advantage, compared to pembrolizumab alone, in >150 subjects with stage III/IV melanoma.
mRNA-4157/V940, which encodes up to 34 neoantigens identified from the patient’s own tumor tissue, is designed to synergize with pembrolizumab to activate antitumor activity of cytotoxic T cells.
PD-1 inhibitors are beneficial in three late-stage trials
PD-1-specific checkpoint inhibitors improved survival in patients with three different cancer types. No specific data have been disclosed.
In the randomized, placebo-controlled Phase 3 NRG-GY018 trial, pembrolizumab with chemotherapy improved progression-free survival, compared to chemotherapy alone, in advanced or recurrent endometrial carcinoma regardless of mismatch repair status.
Another PD-1 inhibitor toripalimab (Junshi Biosciences) along with chemotherapy was beneficial in two randomized, double-blind, placebo-controlled Phase 3 trials, viz., the JUPITER-02 trial with subjects with recurrent or metastatic nasopharyngeal carcinoma and the TORCHLIGHT trial with subjects with recurrent or metastatic triple-negative breast cancer.
Influenza vaccine has been >50% effective this season
Seasonal influenza vaccine has prevented 54% medically attended influenza A cases in US persons aged <65 years this season, according to an interim estimate by the Centers for Disease Control and Prevention.Citation1 Effectiveness against symptomatic disease in children reached 71%.
The influenza vaccine effectiveness, which ranged between 10% and 60% in the last 20 years, is thus higher than usual. However, acceptance rates have been lower than pre-pandemic US rates, particularly in children and pregnant women.
RSV vaccines backed by FDA
An FDA’s advisory panel has recommended the approval of the RSV vaccine RSVpreF (Pfizer) for adults aged 60 years and older. The vaccine demonstrated 67% efficacy in preventing lower respiratory tract infections in clinical trials. The decision was not unanimous due to the risk that vaccinees might develop Guillain-Barré syndrome, albeit at a very low incidence. RSVpreF targets prefusion forms of the F protein from two RSV strains.
The FDA has also granted the fast-track designation to the vaccine IVX-A12 (Icosavax) for prevention of RSV disease in the same age group. IVX-A12, which is being tested in 120 healthy older adults, is a bivalent VLP-based vaccine targeting RSV and the human metapneumovirus, adjuvanted with the squalene-based MF59 adjuvant (Seqirus).
There is no approved RSV vaccine on the market yet.
Bispecific T-cell engager was safe in HIV patients
The engineered, soluble T-cell receptor IMC-M113V (Immunocore) was safe with no serious adverse events in a dose-escalation Phase 1 trial involving 12 chronic HIV patients.
IMC-M113V, which is administered as a single intravenous dose, is a bispecific receptor recognizing a Gag-derived peptide displayed on the surface of infected cells and the CD3 coreceptor, which stimulates cytotoxic T cells brought into close proximity.
CAR-T cell therapy in early trial with multiple myeloma
The autologous CAR-T cell therapy NXC-201 (Nexcella) induced a 90% response rate and a 60% complete response rate in 29 relapsed or refractory multiple myeloma patients who received the therapeutic dose in the Phase 1 NEXICART-1. The treatment was well tolerated, with manageable cytokine-release syndrome and no neurotoxicity.
NXC-201 consists of patients’ own T cells engineered to target the B-cell maturation antigen, which is overexpressed in multiple myeloma cells. Two CAR-T regimens with the same target have been approved for multiple myeloma.
Disclosure statement
No potential conflict of interest was reported by the author(s).