1. Extension of Progression-free survival by 15 months with the addition of IBRANCE to standard-of-care treatment
Pfizer announced Phase 3 randomized, open-label PATINA trial results evaluating the addition of IBRANCE® (palbociclib) to the current standard-of-care maintenance therapy in HR and HER2 double positive metastatic breast cancer patients. The primary endpoint, progression-free survival (PFS) has been improved significantly, where the addition of IBRANCE to the anti-HER2 and anti-endocrine therapy increased the median PFS from 29.1 months to 44.3 months. Approximately 10% of all breast cancers are HR+ and HER2+, IBRANCE served as a CDK4/6 inhibitor suppressing irregular cell proliferation. In 2015, this drug was approved to treat HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor. With the new study results, the indication is expected to be expanded with further review from regulatory authorities.
2. Approval of easily administered pre-filled Vabysmo in the EU
Roche announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Vabysmo is the first bispecific antibody approved for the eye by blocking both Ang-2 and VEGF-A to alleviate inflammation. This new formulation's approval offered a more convenient administration route for vision-loss patients with common causes. The FDA also approved this drug formulation in the U.S. in July 2024.
Link: https://www.roche.com/media/releases/med-cor-2024-12-13b
3. Long-term data demonstrated sustained efficacy of LYNPARZA in breast cancer
AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced long-term results from the OlympiA Phase 3 trial evaluating a PARP inhibitor -LYNPARZA (olaparib) for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. Results showed that LYNPARZA (olaparib) significantly improved overall survival (OS), reducing the risk of death by 28% in patients with a median follow-up of 6.1 years compared to the placebo arm. The drug has also significantly improved invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35% and reduced the risk of distant disease recurrence or death by 35% versus placebo.
4. Tavapadon significantly improved motor control in early Parkinson's disease patients
AbbVie recently announced positive results from its Phase 3 TEMPO-2 trial evaluating an investigational drug, tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon selectively activates D1/D5 dopamine receptors as a once-daily treatment to improve motor control for Parkinson's disease. The trial met its primary endpoint by significantly reducing the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26 compared to the placebo arm. Key secondary endpoints of improvements in motor aspects of experiences of daily living (MDS-UPDRS Part II) were also met. Full results will be released later and the company is filing to submit a New Drug Application to the U.S. FDA in the next year.
5. Kisqali reduced tumor distant recurrence preventing metastasis
Novartis announced results from an updated analysis of the Phase III NATALEE trial of Kisqali® (ribociclib) that underscore the extended efficacy beyond the duration of treatment in combination with endocrine therapy (ET). Results showed a sustained reduction in distant recurrence of 28.5%, compared to ET alone, in patients with stage II and III HR+ and HER2- early breast cancer. Reduction in distant recurrence decreases the cancer returning and spreading to other organs. Ribociclib is also a CDK4/6 inhibitor controlling irregular cell division and proliferation and the drug has been approved regulatory authorities in 99 countries worldwide to treat breast cancer.
6. Reduced risk of death presented by Blenrep from the ongoing trial
GSK announced that Blenrep (belantamab mafodotin) could significantly reduce the risk of death in multiple myeloma at or after the first relapse. The results were obtained from DREAMM-7 trial evaluating Blenrep (belantamab mafodotin) versus daratumumab in combination with bortezomib plus dexamethasone as a second-line or later treatment for relapsed or refractory multiple myeloma. With a median follow-up of 39.4 months, the analysis showed a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination versus the daratumumab-based arm. Although the median overall survival was not reached in either arm of the study, the projected mOS for is 84 months compared to 51 months, respectively. The belantamab mafodotin combination also showed statistically significant superiority on the key secondary endpoint of minimal residual disease negativity, referring to no detectable cancer cells compared to the daratumumab combination. Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. It is promising to serve as a maintenance therapy preventing cancer recurrence.
7. Pirtobrutinib showed superior efficacy in targeting a certain type of blood cancer cells
Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent BTK inhibitor in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a covalent BTK inhibitor. At median follow-up of approximately 19 months, the median PFS was 14.0 months for the pirtobrutinib arm compared to 8.7 months for the control arm, reducing the risk of relapse, disease or death by 46%. The new regime also demonstrated clinically meaningful improvements in other secondary endpoints such as investigator-assessed PFS (15.3 vs. 9.2 months), event-free survival (14.1 vs. 7.6 months), and time to the next treatment (23.9 vs. 10.9 months). Pirtobrutinib is currently approved as Jaypirca® under the U.S. FDA for certain indications, the updated study results will support further expansion of indications.
8. Long-term data of CAR-T therapy showed persistent high efficacy after five years
Kite, a Gilead Company focusing on cellular therapy announced results from a five-year follow-up analysis of Phase 2 ZUMA-5 study evaluating Yescarta® (axicabtagene ciloleucel, a CD19-directed CAR-T therapy) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL). Long-term data patients treated with Yescarta continued to experience durable responses and long-term survival a few years after treatment. At a median follow-up of 64.6 months, the overall response rate was 90% and the complete response was 75%. Moreover, the median duration of response was 60.4 months and median progression-free survival was 62.2 months. Relapsed or refractory non-Hodgkin lymphomas are normally recognized as incurable due to ultimately relapsing, however, Yescarta can offer a longer period of protection from cancer recurrence for patients.
9. Drugs received positive recommendations from EU CHMP
Company | Drug | Target | Type | Indication |
Merck | WELIREG® (belzutifan) | Selective 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(1) |
Merck | WELIREG® (belzutifan) | Selective HIF-2α inhibitor | Monotherapy | Adult patients with advanced clear cell renal cell carcinoma (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(1) |
Gilead | Seladelpar in combination with ursodeoxycholic acid | PPAR-delta agonist | Combination | Adult patients with primary biliary cholangitis who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA(2) |
Bayer, BridgeBio | Acoramidis | Transthyretin stabilizer | Monotherapy | Wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)(3) |
CSL | Garadacimab | Activated factor XII (factor XIIa) inhibitor | Monotherapy | Adult and adolescent patients aged 12 years and older with hereditary angioedema (HAE) conditions(4) |
Eli Lilly and Company | Omvoh® (mirikizumab) | Inerleukin-23p19 (IL-23p19) antagonist | Monotherapy | Adults with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment(5) |
Post comments