1. Vepdegestrant met its Phase 3 VERITAC-2 trial endpoint, improving PFS in ESR1-mutant ER+/HER2- breast cancer
On March 11, 2025, Pfizer and Arvinas announced positive topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with ER+/HER2- advanced or metastatic breast cancer and did not show improvement with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. Vepdegestrant is an investigational oral PROTAC ER degrader to target and degrade the estrogen receptor. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, with a significant improvement in progression-free survival (PFS) compared to fulvestrant. However, the overall survival data is still not mature yet.
2. Doravirine/islatravir showed potential as a novel HIV-1 treatment without an integrase inhibitor
On March 12, 2025, Merck announced two trial results regarding the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir for HIV-1 Viral Suppression. MK-8591A-052 trial compared the new regime to bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF) alafenamide and in trial MK-8591A-051, it was compared to the baseline antiretroviral therapy (bART). The regime is a novel nucleoside reverse transcriptase translocation inhibitor therapy without the involvement of intergrade inhibitor. In both trials, doravirine/islatravir met the primary efficacy success for non-inferiority to comparator antiretroviral therapies. In the double-blind trial MK-8591A-052, at Week 48, 91.5% of participants who switched to doravirine/islatravir maintained viral suppression (HIV-1 RNA <50 copies/mL) compared to 94.2% of participants who continued receiving BIC/FTC/TAF. While, in the open-label trial MK-8591A-051, at Week 48, 95.6% of participants who switched to doravirine/islatravir maintained viral suppression compared to 91.9% of participants who continued on bART.
3. ELAHERE® reduced the risk of tumor progression in FRα-positive platinum-resistant ovarian cancer
On March 15, 2025, AbbVie announced results from the confirmatory Phase 3 MIRASOL trial evaluating the efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) targeting FRα together with the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the cancer cells. At the 30.5-month median follow-up, ELAHERE reduced the risk of tumor progression or death by 37% with a median progression-free survival of 5.59 months versus 3.98 months in the chemotherapy arm. The overall survival data for patients receiving ELAHERE was 6.85 months, while the chemotherapy arm showed 13.34 months.
4. Expanded approval of Breyanzi® for relapsed or refractory follicular lymphoma
On March 14, 2025, BMS announced that the expanded approval from the European commission on Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy in treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval was supported by the results of the global, Phase 2 TRANSCEND FL study. In the trial, both primary and secondary endpoints were met, with an overall response rate of 97.1% and a complete response (CR) rate of 94.2%, respectively. Moreover, the median time to the first response was 0.95 months and 75.7% of the patients were still in response at 18 months.
5. Icotrokinra showed a higher response rate and lower clinical remission
On March 10, 2025, Johnson & Johnson announced positive results regarding icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor to treat adults with moderately to severely active ulcerative colitis (UC). In the ANTHEM-UC study, three doses of once-daily icotrokinra were tested and all met the primary endpoint of clinical response at Week 12. For patients treated with the highest dose, a 63.5% response rate was achieved compared to 27% for placebo and 30.2% showed clinical remission compared to 11.1% of patients who received placebo.
6. UPLIZNA® improved MG-ADL and QMG scores in AChR+ generalized myasthenia gravis patients
On March 13, 2025, Amgen announced data from the Phase 3 MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). It is a rare autoimmune disorder characterized by muscle weakness due to disrupted neuromuscular transmission. The trial demonstrated continued improvement in efficacy of UPLIZNA compared to placebo as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ subpopulation through week 52. Among the AChR+ patients, 72.3% had a ≥ 3-point improvement in the MG-ADL score, compared to 45.2% in placebo. There was also an improvement in the Quantitative Myasthenia Gravis (QMG) score for patients in the UPLIZNA group as compared to placebo at Week 52.
7. Subcutaneous CagriSema successfully reduced weights in people who are with obesity or overweight together with type 2 diabetes
On 10 March 2025, Novo Nordisk announced results from the phase 3 REDEFINE 2 trial in the global REDEFINE programme. The trial investigated once-weekly subcutaneous CagriSema compared to placebo in people with obesity or overweight and type 2 diabetes for 68 weeks. CagriSema is a combination of dual hormone analogues, with an amylin analogue, Cagrilintide and a GLP-1 receptor agonist, Semaglutide. The trial achieved its primary endpoint by demonstrating a statistically significant weight loss at week 68 with CagriSema versus placebo. As for the co-primary endpoint, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with the placebo. 89.7% of patients achieved weight loss of 5% or more after 68 weeks compared to 30.3% in the placebo arm.
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