1. Global Phase 3 SKYSCRAPER-01 Trial failed to reach the primary endpoint
Roche recently announced that their global phase III SKYSCRAPER-01 study did not meet the expected primary endpoint of overall survival. The study investigated tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC). The trial was a randomised, double-blind study involving 534 patients. The company announced the data will be continuously reviewed and the trial will be further optimised. Tiragolumab is a checkpoint inhibitor targeting TIGIT while atezolizumab selectively blocks PD-L1. TIGIT works by binding to CD155 on tumor cells preventing its interaction with CD226, resulting in immune suppression. Currently, multiple trials focuse on this target, but none of the candidates have been officially approved in the market.
Source: https://www.roche.com/media/releases/med-cor-2024-11-26
2. Merck’s WINREVAIR achieved the primary endpoint and has been recommended to initiate future open-label studies
Merck, known as MSD outside of the United States and Canada, announced positive results from the Phase 3 ZENITH study evaluating effects of WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality. PAH is characterized by elevated blood pressure in the arteries that carry blood from the heart to the lungs, which leads to fatal if left untreated. WHO has grouped the disease into four functional classes according to the severity of the condition. The above study has shown both statistically and clinically meaningful improvement in reducing the risk of morbidity or mortality events compared to the placebo group with background treatment. The primary endpoint of time to the first morbidity or mortality event was achieved. Moreover, the current trial has been recommended to be stopped and changed to an open-label study where all participants are entitled to receive WINREVAIR. WINREVAIR is an FDA-approved protein drug inhibiting activin signalling to reduce inflammation and inhibit the proliferation of endothelial and smooth muscle cells in diseased vasculature.
Source: https://www.merck.com/news/merck-announces-pivotal-phase-3-zenith-trial-evaluating-winrevair-sotatercept-csrk-met-primary-endpoint-at-interim-analysis/; https://www.phaeurope.org/about-ph/classification-and-who-functional-class/;
https://www.merckconnect.com/winrevair/mechanism-of-action/
3. Combination therapy of Kisqali® (ribociclib) was approved by the European Commission for patients with HR+/HER2- early breast cancer
Novartis announced that the European Commission (EC) has approved Kisqali® (ribociclib) in combination with an aromatase inhibitor for the treatment of patients with HR+/HER2- early breast cancer at high risk of recurrence. Kisqali® (ribociclib) limits the cancer progression by selectively inhibiting cyclin-dependent kinase 4 and 6 (CDK4/6). The approval was based on the Phase III NATALEE study which recruited a broad patient population with HR+/HER2- stage II and III disease. There was a 25.1% decrease in risk of disease recurrence with combination therapy compared to the endocrine therapy alone. This approval followed U.S. FDA approval on September 17, 2024, and the regulatory review of this drug is still ongoing worldwide.
4. CAPItello-281 Phase III trial has met its primary endpoint in treating prostate cancer with PTEN mutation
AstraZeneca’s CAPItello-281 Phase III trial showed Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a significant improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient denovo metastatic hormone-sensitive prostate cancer (mHSPC). PTEN is a tumor suppressor gene regulating normal cell division and preventing uncontrolled cell growth. Meanwhile, the overall survival (secondary endpoint) is still not mature enough to conclude. The safety profile is consistent with the known profile and full data will be shared with global regulatory authorities. Truqap is an adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3) and it has been approved for specific types of breast cancers previously.
5. Approval of fully liquid Menveo meningococcal vaccine by EU
GSK announced that the European Commission has approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by meningococcal bacterial serogroups A, C, W and Y. It is now licenced for active immunisation of children from 2 years of age, adolescents and adults. The original Menveo vaccine that requires reconstitution was approved in 2010. The new approval was based on two Phase III clinical studies demonstrating non-inferiority of the liquid formulation compared to the current licensed vaccine with comparable serum antibody levels.
Source: https://www.gsk.com/en-gb/media/press-releases/gsk-s-fully-liquid-menveo-meningococcal-vaccine-approved-by-european-commission/; https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results;
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results
6. Boehringer Ingelheim launched two new therapies for dogs
Boehringer Ingelheim is a pharma company leading in animal healthcare, recently two products for dogs have been released. Firstly they launched an FDA-approved oral solution - VETMEDIN® which is for the management of congestive heart failure (CHF) in dogs. The liquid version offered a more convenient option for owners to manage their pets’ condition. VETMEDIN® could help increase the survival time and quality of life in dogs. Meanwhile, the company has also launched the EURICAN® L4 vaccine targeting key Leptospira serogroups. Infection from this bacteria could potentially be life-threatening. The drug could also help block the transmission of disease from dogs to the human population.
7. 52-week results of MariTide showed promising results in managing obesity and overweight patients
Amgen announced positive data from a 52-week double-blinded Phase 2 study investigating the effects of MariTide (maridebart cafraglutide) treating obesity or overweight without Type 2 diabetes. MariTide is a bispecific glucagon-like peptide 1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist The drug showed a maximum of 0% average weight loss at week 52 without a weight loss plateau. There was also a 17% average weight loss in those patients who were non-responsive to GLP-1 therapies. Moreover, MariTide also showed improvements in cardiometabolic parameters, including blood pressure, triglycerides and high-sensitivity C-reactive protein. Part 2 of the Phase 2 study will continue to investigate the drug beyond 52 weeks to evaluate further weight loss with continued treatment, weight maintenance through less frequent or lower dosing and durability of weight loss after discontinuation of MariTide. Before this new study update, some news reported that administering this drug could decrease bone density, leading to a drop in the company's stock. In response, Amgen issued an official statement asserting that there is no link between MariTide and bone density loss.
Source: https://www.amgen.com/newsroom/press-releases/2024/11/amgen-announces-robust-weight-loss-with-maritide-in-people-living-with-obesity-or-overweight-at-52-weeks-in-a-phase-2-study; https://www.cnbc.com/2024/11/12/amgen-stock-falls-on-weight-loss-drugs-bone-density-loss data.html#:~:text=Amgen%20said%20there%20is%20no,billion%20from%20its%20market%20value.
8. BeiGene’s TEVIMBRA® (tislelizumab) has been approved by EU with two new indications on ESCC and adenocarcinoma
BeiGene (soon to be renamed BeOne) announced that the European Commission has approved TEVIMBRA® (tislelizumab) for first-line treatment in two indications:
Esophageal Squamous Cell Carcinoma (ESCC): Approved in combination with platinum-based chemotherapy, based on the Phase 3 RATIONALE-306 trial. The study demonstrated a significant improvement in median overall survival (OS): 17.2 months for TEVIMBRA with chemotherapy versus 10.6 months for placebo with chemotherapy, representing a 34% reduction in the risk of death.
Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma: Approved in combination with platinum- and fluoropyrimidine-based chemotherapy, supported by the Phase 3 RATIONALE-305 trial. The primary endpoint of median OS was 15.0 months for the combination therapy compared to 12.9 months for placebo with chemotherapy, showing a 20% reduction in the risk of death.
Both studies reported improved survival outcomes in patients whose tumors expressed PD-L1 in more than 5% of cells. TEVIMBRA is an IgG4 anti-PD-1 monoclonal antibody engineered for high affinity and binding specificity. This design minimizes current non-specific binding to Fc-gamma (Fcγ) receptors on macrophages, potentially enhancing its anti-tumor efficacy.
Source: https://ir.beigene.com/news/european-commission-approves-beigene-s-tevimbra-for-first-line-treatment-of-advanced-metastatic-esophageal-squamous-cell-carcinoma-and/22ce8afc-1ba7-4525-82dd-058f6cfea63c/
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