AEMPS Issues IPT for Oncological Drugs
- Madrid, Spain – Teh Spanish Agency for Medicines and Health Products (AEMPS) has released four new therapeutic positioning reports (IPTs), offering insights into novel treatment options.
- One IPT examines Rank (tislelizumab, Beigene) as a monotherapy for adult patients battling irresecable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior...
- The trial indicated Rank's statistically important superiority over chemotherapy using docetaxel, paclitaxel, or irinotecan in treating advanced, recurring, or metastatic ESCC in patients previously treated with...
spanish Agency for Medicines Issues New Therapeutic Positioning Reports
Table of Contents
- spanish Agency for Medicines Issues New Therapeutic Positioning Reports
- New Therapeutic Options: Insights from the Spanish Agency for Medicines
- What are IPTs and Why are They Important?
- Treatments for Cancer
- Rank (Tislelizumab) for Esophageal Squamous Cell Carcinoma (ESCC)
- Tepkinly (Epcoritamab) for Follicular Lymphoma
- Braft (Encorafenib) and Mektovi (Binimetinib) for Non-Small Cell Lung Cancer (NSCLC)
- Vabysmo (Faricimab) for Macular Edema
- Where Can I Find More Information?
Madrid, Spain – Teh Spanish Agency for Medicines and Health Products (AEMPS) has released four new therapeutic positioning reports (IPTs), offering insights into novel treatment options. Three of these reports focus on oncological medicines, while the fourth addresses secondary macular edema.
Rank for Esophageal Cancer
One IPT examines Rank (tislelizumab, Beigene) as a monotherapy for adult patients battling irresecable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Authorization stemmed from the BGB-A317-302 (Ratione-302) trial.
The trial indicated Rank’s statistically important superiority over chemotherapy using docetaxel, paclitaxel, or irinotecan in treating advanced, recurring, or metastatic ESCC in patients previously treated with platinum-based chemotherapy.The IPT notes a 2.3-month advancement in overall survival. The AEMPS considers this result clinically relevant, especially given the generally poor prognosis for patients with advanced ESCC.
Tepkinly for Follicular Lymphoma
Another report assesses tepkinly (epcoritamab, AbbVie) as a monotherapy for follicular lymphoma (FL) that has relapsed or is refractory after two or more lines of systemic treatment.The evaluation is based on clinical data from the GCT3013-01 pivotal study and the GCT3013-04 support study.
Both studies involved subjects with relapsed or refractory FL who had received at least two prior systemic therapies. After a median follow-up of 17.4 months, the studies demonstrated an overall response rate of 82.6%, with 97 subjects achieving a complete response (62.6%).The duration of response had not been reached by the data cutoff date. In subjects with FL, the overall response rate was 82%, with 80 (62.5%) and 25 (19.5%) subjects achieving complete and partial responses,respectively.
Braft and Mektovi Combination for Non-Small Cell lung Cancer
The third oncology-related IPT focuses on Braft (encorafenib, Pierre Fabre) in combination with Mektovi (binimetinib, Pierre Fabre) for treating adult patients with advanced non-small cell lung cancer (NSCLC) harboring the V600E BRAF mutation.
Efficacy was evaluated in the Pharos study,an open-label,phase II,multicenter,multinational trial involving 56 centers across five countries. The study investigated two cohorts: patients with NSCLC who had not received prior treatment and those who had been previously treated. The primary endpoint, overall response rate, was 63.3% in the global Pharos population. the combination treatment showed differences between subgroups: an overall response rate of 74.6% in treatment-naïve patients (n=59) compared to 46.3% in previously treated patients (n=39). The duration of response was 40.0 months in treatment-naïve patients and 16.7 months in previously treated patients.
Vabysmo for Macular Edema
Outside of oncology, a report addresses Vabysmo (faricimab, Roche) for treating adult patients with visual impairment due to macular edema secondary to retinal vein occlusion: either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
It’s efficacy and safety were evaluated in two randomized, multicenter, double-masked studies controlled with an active comparator (aflibercept) in a non-inferiority design over 72 weeks.
According to the AEMPS, treatment with Vabysmo proved to be non-inferior to aflibercept in two randomized clinical trials: the Balaton study (for patients with BRVO) and the Comino study (for patients with CRVO). At week 24,the difference between treatment arms in change in best-corrected visual acuity (BCVA) from baseline was -0.6 letters in the Balaton study and -0.4 letters in the comino study,within the agreed non-inferiority margin of -4 letters. Sensitivity analyses were consistent with the main analyses. Part two of the Balaton and Comino studies indicated that visual acuity improvements obtained during the first 24 weeks could be maintained with extended faricimab injection intervals: 81.5% and 74.0% of patients in the Balaton and Comino studies, respectively, maintained treatment intervals every 12 or 16 weeks.
New Therapeutic Options: Insights from the Spanish Agency for Medicines
The Spanish Agency for Medicines and Health products (AEMPS) recently released four new therapeutic positioning reports (IPTs), offering valuable insights into novel treatment options for a variety of conditions. This article will break down each of these reports in a clear Q&A format, addressing common questions and providing helpful context.
What are IPTs and Why are They Important?
Q: What exactly is an IPT,and why should I care?
A: An IPT,or Therapeutic Positioning Report,is a report issued by the AEMPS in Spain. These reports assess new medications and provide recommendations on how they should be used within the Spanish healthcare system. They evaluate a drug’s efficacy, safety, and place in therapy relative to existing treatments. they are important because they help guide doctors and patients on the effectiveness and appropriate use of new medicines.
Treatments for Cancer
Focusing on three of the newest treatments for different types of cancer.
Rank (Tislelizumab) for Esophageal Squamous Cell Carcinoma (ESCC)
Q: What is Rank, and what is it used for?
A: Rank (tislelizumab) is a medication used as a monotherapy – meaning that it used on its own- for adult patients with irresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC). It is used in patients who have already undergone prior platinum-based chemotherapy.
Q: How effective is Rank in treating ESCC?
A:The Ratione-302 trial demonstrated that Rank is superior to chemotherapy (docetaxel, paclitaxel, or irinotecan) in the patient population. The overall survival improved by 2.3 months in patients with ESCC after exhausting prior chemotherapy.
Q: What makes this result clinically relevant?
A: ESCC often has a poor prognosis, so any advancement in overall survival is considered a clinically relevant. The AEMPS highlighted the importance of this result due to the limited treatment options available for advanced ESCC.
Tepkinly (Epcoritamab) for Follicular Lymphoma
Q: What is Tepkinly, and what does it treat?
A: Tepkinly (epcoritamab) is a monotherapy for relapsed or refractory follicular lymphoma (FL). This means it’s used to treat FL that has returned or stopped responding to previous treatments.
Q: What are the key findings from the studies on Tepkinly?
A: The GCT3013-01 and GCT3013-04 studies showed impressive results:
- Overall Response Rate: 82.6%
- Complete Response: 62.6%
In patients specifically with FL, the overall response rate was 82%, with 62.5% achieving complete respone and 19.5% with a partial response.
Q: How is Tepkinly different from other treatments for FL?
A: This data it not included, but likely differs in its mechanism of action or type of patient receiving treatment compared to previous forms of care.
Braft (Encorafenib) and Mektovi (Binimetinib) for Non-Small Cell Lung Cancer (NSCLC)
Q: What is the Braft and Mektovi combination used for?
A: This combination is used to treat adult patients with advanced non-small cell lung cancer (NSCLC) who have the V600E BRAF mutation. The combination targets this specific mutation within the cancer cells.
Q: What did the Pharos study show regarding the efficacy of this combination?
A: The primary endpoint was the overall response rate. The Pharos study demonstrated an overall response rate of 63.3% in the global population. When broken down into subgroups, the following results were observed:
- Treatment-Naïve Patients: 74.6% overall response rate, with the duration of response being 40.0 months..
- Previously Treated Patients: 46.3% overall response rate, with the duration of response being 16.7 months.
Vabysmo (Faricimab) for Macular Edema
Q: What is Vabysmo used for?
A: vabysmo (faricimab) is used to treat adult patients with visual impairment caused by macular edema secondary to retinal vein occlusion (RVO). RVO includes branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
Q: What were the major findings from the Balaton and Comino Studies?
A: the studies compared Vabysmo to Aflibercept:
- Non-inferiority: Vabysmo was shown to be non-inferior to aflibercept in visual acuity improvement in both studies, at week 24.
- Extended Intervals: Part two indicated that visual acuity improvements could be maintained with extended faricimab injection intervals.
Q: What are the key differences between Vabysmo and other drugs used for macular edema?
A: The source article does not offer a comparison against other drugs. You may see yoru doctor for specific details during your visit.
| Treatment | Indication | Key Finding Highlight |
|---|---|---|
| Rank (Tislelizumab) | ESCC (Esophageal Squamous Cell Carcinoma) | 2.3-month improvement in overall survival |
| Tepkinly (Epcoritamab) | Relapsed or Refractory Follicular Lymphoma | 82.6% overall response rate (complete response in 62.6%) |
| Braft (Encorafenib) + Mektovi (Binimetinib) | NSCLC (Non-Small Cell Lung Cancer) with V600E BRAF mutation | 63.3% overall response rate |
| Vabysmo (Faricimab) | Macular Edema secondary to RVO (BRVO/CRVO) | Non-inferior to aflibercept with potential for extended dosing intervals. |
Where Can I Find More Information?
Q: How can I learn more about these medications and their use?
A: You can consult with your doctor or other healthcare provider. Additionally, the AEMPS website is a good resource, and clinical trials are usually available to view on websites like ClinicalTrials.gov.