1. PADCEV® with KEYTRUDA® reduce the risk of death in patients with urothelial cancer
On February 10, 2025, Pfizer and Astellas Pharma announced follow-up results from the Phase 3 EV-302 clinical trial evaluating the efficacy and safety of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® in patents with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). PADCEV® is an antibody-drug conjugate targeting Nectin-4, which is highly expressed on bladder cells. Results showed that PADCEV® plus KEYTRUDA® reduced the risk of death by 49% versus chemotherapy. The median of overall survival and progression-free survival of combination therapy was 33.8 months and 12.5 months versus 15.9 months and 6.3 months, respectively, for chemotherapy. The combination therapy has been approved to treat adult patients with la/mUC by the authorities from the United States, the European Union, Japan and other countries.
2. TALZENNA® with XTANDI® showed improvement in both patients with and without gene mutation
On February 13, 2025, Pfizer announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), which is an oral poly ADP-ribose polymerase inhibitor. The trial evaluates TALZENNA® combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor in treating metastatic castration-resistant prostate cancer (mCRPC), with or without ehomologous recombination repair (HRR) gene mutations. The study evaluated two cohorts, an unselected group and a selected HRR gene-mutation group. The median overall survival in the unselected group was 45.8 months with TALZENNA® in combination with XTANDI® and 37.0 months with XTANDI® and placebo. In the other cohort, the median OS was 45.1 months with TALZENNA® in combination with XTANDI® and 31.1 months with XTANDI and placebo, representing a 38% reduction in the risk of death. The U.S. FDA previously approved the combination therapy in June 2023.
3. Positive results of Breyanzi® on the fifth indication indolent B-cell non-Hodgkin lymphoma
On February 10, 2025, BMS announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma. The study met its primary endpoint in the marginal zone lymphoma (MZL) cohort with a statistically significant and clinically meaningful improvement in the overall response rate. The study also met the key secondary endpoint of complete response rate (CRR). Breyanzi is a CD19-directed CAR T cell therapy, the fifth cancer type showing clinical benefit.
Link: https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-for-Breyanzi-lisocabtagene-maraleucel-in-Adult-Patients-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma/default.aspx
4. Opdualag™ trial failed to meet the primary endpoint to treat patients with completely resected stage III-IV melanoma
On February 13, 2025, BMS announced that the Phase 3 RELATIVITY-098 trial did not meet its primary endpoint of recurrence-free survival (RFS). The study evaluates Opdualag™ (nivolumab and relatlimab-rmbw) for the adjuvant treatment of patients with completely resected stage III-IV melanoma. The therapy combines both programmed death-1 (PD-1) inhibitor nivolumab and the lymphocyte activation gene 3 (LAG-3) blocking antibody relatlimab. The failure might indicate that LAG-3 inhibition in the adjuvant setting may not be efficient due to limited antitumor T cell counts in those patients.
Link: https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Provides-Update-on-Phase-3-RELATIVITY-098-Trial/default.aspx
5. Termination of the vaccine trial on pathogenic E. coli due to insufficient efficacy
On February 13, 2025, an independent data monitoring committee reviewed the Johnson & Johnson and Sanofi’s investigational vaccine candidate (ExPEC9V) for extraintestinal pathogenic E. coli (ExPEC) disease and declared that it was not sufficiently efficacious at preventing invasive E. coli disease (IED) compared to placebo among study participants. Due to the IDMC’s determination, the study is being discontinued.
Link: https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-phase-3-e-mbrace-study
6. Darolutamide plus androgen deprivation therapy delayed disease progression
in both high and low-volume metastatic hormone-sensitive prostate cancer: On February 13, 2025, Bayer showed new analysis data from the Phase III ARANOTE trial. The study showed that darolutamide plus androgen deprivation therapy (ADT) improved radiological progression-free survival (rPFS) in patients with high and low-volume metastatic hormone-sensitive prostate cancer (mHSPC) by 40% and 70%, respectively, compared to placebo plus ADT. Previous results showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT. Darolutamide is already approved in mHSPC, under the brand name Nubeqa™, in combination with ADT and docetaxel in over 80 markets around the world.
Link: https://www.bayer.com/media/en-us/new-data-for-darolutamide-confirm-safety-and-improved-efficacy-across-subgroups-of-patients-with-metastatic-hormone-sensitive-prostate-cancer/
7. Nerandomilast trial met its primary endpoint in treating progressive pulmonary fibrosis
On February 10, 2025, Boehringer Ingelheim announced that the Phase III FIBRONEER™-ILD trial evaluating the investigational compound nerandomilast in progressive pulmonary fibrosis met its primary endpoint. There was an absolute change from baseline in forced vital capacity (FVC, a measure of lung function) at week 52 versus placebo. Nerandomilast is an investigational oral inhibitor of phosphodiesterase 4B (PDE4B). Based on these results, Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of progressive pulmonary fibrosis.
Link: https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/nerandomilast-primary-endpoint-phase-3-fibroneer-ild-pulmonary-fibrosis
8. Drugs approved by the U.S. FDA
Company | Drug | Target | Type | Indication |
GSK | Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) | / | Vaccine | Individuals aged 10 through 25 years to help protect against MenABCWY |
Pfizer | ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product | CD30 | Combination | Adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy |
Roche | Evrysdi® (risdiplam) tablet - survival motor neuron 2 (SMN2) pre-mRNA splicing modifier | SMN2 gene | Monotherapy | People living with spinal muscular atrophy (SMA) |
Astellas | IZERVAY™ (avacincaptad pegol intravitreal solution) | complement protein C5 inhibitor | RNA aptamer | Geographic atrophy (GA) secondary to age-related macular degeneration (AMD). |
https://www.roche.com/media/releases/med-cor-2025-02-12
https://www.astellas.com/en/news/29641
9. Drugs approved by the EU
Company | Drug | Target | Type | Indication |
Bayer | Beyonttra™ (acoramidis) | Transthyretin (TTR) stabilizer | Monotherapy | Wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) |
MERCK | WELIREG® (belzutifan) | Hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor | Monotherapy | Adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; Adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies |
CSL and Arcturus Therapeutics | KOSTAIVE® (a self-amplifying mRNA COVID-19 vaccine) | / | Vaccine | Individuals 18 years and older |
Link:
https://www.bayer.com/media/en-us/heart-drug-beyonttra-acoramidis-approved-in-eu-for-treatment-of-transthyretin-amyloidosis-in-adults-with-cardiomyopathy/
https://www.merck.com/news/welireg-belzutifan-receives-first-european-commission-approval-for-two-indications/
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