Name:
Ixazomib-lenalidomide-dexamethasone in routine clinical practice
Description:
Ixazomib-lenalidomide-dexamethasone in routine clinical practice
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T00H11M35S
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https://cadmoreoriginalmedia.blob.core.windows.net/95cbcf80-eacc-4cf5-a9c2-f6021982678b/Hajek Presentation - V7.mp4?sv=2019-02-02&sr=c&sig=gsjJsodCfWWjTClduf0UTWZ03zJN%2FqwVnViJIJ5j3fk%3D&st=2024-11-24T13%3A16%3A11Z&se=2024-11-24T15%3A21%3A11Z&sp=r
Upload Date:
2024-04-30T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[MUSIC PLAYING]
ROMAN HÁJEK: Hello, and welcome to this video summarizing our article entitled "Ixazomib lenalidomide dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma," which was recently published in Future Oncology. I am Professor Roman Hájek. I'm head of Department of Haemato-oncology at the University Hospital Ostrava in the Czech Republic, and the lead author of this paper.
Segment:1 What was the purpose of this study?.
ROMAN HÁJEK: It's widely acknowledged that the clinical outcome in a routine clinical practice is often different from those reported in clinical trials of multiple myeloma therapies. Why is this? Because inclusion of exclusion criteria. Differences in patients characteristics and the strict eligibility criteria used for enrollment in clinical trials largely contribute to this gap in effectiveness versus efficacy.
ROMAN HÁJEK: Analysis show that up to 72% of real-world patients with relapsed or refractory myeloma will not meet the eligibility criteria for clinical trials. Differences in patients' outcomes may also arise from a shorter duration of therapy achieved in the real world versus the clinical trials setting due to several factors including patients and/or physician preferences, treatment convenience, and treatment center policies or procedures.
ROMAN HÁJEK: Observational studies can provide important information on the effectiveness and safety of new therapies in a routine clinical practice as they have less stringent inclusion criteria and consequently include a more diverse patient population that is often underrepresented in clinical trials. Ixazomib is the first oral proteasome inhibitor approved for the treatment of multiple myeloma.
ROMAN HÁJEK: It has been approved in more than 70 countries in combination with the lenalidomide and dexamethasone to treat patients who have received at least one prior therapy. These approvals were based on the results of the Phase III randomized double- blind TOURMALINE-MM1 study, which demonstrated a significantly longer progression-free survival with ixazomib, lenalidomide, and dexamethasone, which from now on I will refer to as IxaRD compared with placebo lenalidomide and dexamesathone.
ROMAN HÁJEK: Response rates were also significantly improved. Evidence from several observational studies suggest that outcomes for patients with multiple myeloma treated with ixazomib in routine clinical practice may be broadly comparable to those observed in the phase three TOURMALINE-MM1 study. However, long term data in a large varied and unselected patient populations are lacking.
ROMAN HÁJEK: We therefore perform and pool analyses of the INSIGHT MM observational study, and a Czech Registry of Monoclonal Gammopathies, or RMG for short, to evaluate the effectiveness and safety of IxaRD in patients with the relapsed/refractory multiple
Segment:2 How was the study undertaken?.
ROMAN HÁJEK: myeloma in routine clinical practice. INSIGHT MM is the largest global prospective observational study conducted in multiple myeloma patients today.
ROMAN HÁJEK: It has enrolled more than 4,300 adult patients with newly diagnosed or relapsed/refractory multiple myeloma in 15 countries worldwide. INSIGHT MM is following patients for an extended period of time to track patterns of disease presentation, patient characteristic, treatment patterns, clinical outcomes, and of course safety. The Czech RMG includes clinical data on diagnosis, treatment, clinical outcomes, safety, and survival for more than 7,000 patients with multiple myeloma in the Czech Republic and Slovakia.
ROMAN HÁJEK: For this analysis, we identified adult patients with relapsed/refractory multiple myeloma who had received at least one prior therapy, and who had been treated with IxaRD. Individual patient level data from INSIGHT MM and to Czech RMG database where pooled and analyzed. Data included patients demographics, disease characteristics, treatment history, treatment effectiveness, and safety.
ROMAN HÁJEK: We analyzed data from 2016 to 2019 from INSIGHT MM, and for 2007 to 2020 for the Czech RMG.
Segment:3 What were the results?.
ROMAN HÁJEK: We identified a total of 263 patients from 13 countries, with 132 patients from INSIGHT MM and 131 from the Czech RMG. After the Czech Republic, most patients were from the United Kingdom and the United States.
ROMAN HÁJEK: The overall median age of patients at the start of IxaRD therapy was 68 years, with 15% of patients aged more than 75 years. Across all lines, 35% of patients had international staging system stage three at diagnosis. Patients had received a median of two prior lines of treatment before starting IxaRD. Overall, 44% of patients received IxaRD as second line, 35% as third line, 11% as fourth line therapy, and 10% as fifth line therapy or later.
ROMAN HÁJEK: Across lines, treatments received prior to IxaRD included bortezomib in 90% and lenalidomide in 27% of patients. 10% of patients were refractory to prior treatment with proteasome inhibitor, and 7% of patients were refractory to lenalidomide. 86% of the patients received IxaRD at an academic or university facility, while 14% were treated in a community hospital or clinic.
ROMAN HÁJEK: Among 186 available patients, the combined overall response rate for IxaRD was 73%, including 37% of patients with a very good partial response or better. Across all patients in this analysis, the median follow up was close to 15 months. The median duration of therapy with IxaRD was 11.8 months. The median time to next therapy was 33 months.
ROMAN HÁJEK: And the median progression free survival was 21.2 months. At the time of analysis, median overall survival had not yet been reached. When analyzed by line of therapy at which patients received IxaRD duration of treatment, time to next therapy, progression free survival, and overall survival all tended to be longer in patients receiving IxaRD in second or third line, shown in blue and green in the figures, compared with those treated in fourth or beyond, showed in purple and red.
ROMAN HÁJEK: With respect to safety, ixazomib dose reduction were required in 17% of patients, while lenalidomide dose reduction were needed in 36% of patients. Adverse events leading to those reductions included hematologic and gastrointestinal toxicities and fatigue. Due to adverse events, a total of 32% of patients discontinued ixazomib, and 30% discontinued lenalidomide.
ROMAN HÁJEK: The most common adverse events leading to discontinuations were infections and hematologic toxicity for both agents.
Segment:4 What is the significance of these findings?.
ROMAN HÁJEK: The findings from this large report analysis show that the effectiveness of IxaRD in routine clinical practice is similar to the efficacy of IxaRD reported in the phase three registrational TOURMALINE-MM1 trial, in which an overall response rate of 78% and a median progression free survival of 20.6 months were reported.
ROMAN HÁJEK: This similarity between efficacy and effectiveness was observed despite our population having more advanced disease and being more heavily pretreated than patients in the TOURMALINE-MM1 study, including a higher proportion of patients who had prior exposure to proteasome inhibitors and immunomodulatory drugs, as well as a proportion of patients refractory to proteasome inhibitors or to lenalidomide.
ROMAN HÁJEK: From a safety perspective, we found IxaRD to be well tolerated with no new safety signal or concerns. Additionally, rates of dose reductions and discontinuations due to adverse events were similar to those reported TOURMALINE-MM1. The all oral IxaRD regimen represents a convenient treatment approach for patients who may find it difficult to assess infusion centers or who do not want to travel to a hospital or clinical setting to receive treatment.
ROMAN HÁJEK: We believe that data such as these are important as they help to build a more complete picture of clinical effectiveness and develop confidence in the use of new treatment in routine clinical practice. This, in turn, should lead to better outcomes for patients with multiple myeloma. Thank you for watching. [MUSIC PLAYING]
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