How effective is Ninlaro (ixazomib)?
Ninlaro (ixazomib) is an oral targeted therapy anticancer drug that is used in combination with lenalidomide (Revlimid) and dexamethasone to treat multiple myeloma (MM).
Clinical trials have been completed using combination treatment of Ninlaro, lenalidomide (Revlimid) and dexamethasone against the combination treatment of placebo, lenalidomide (Revlimid) and dexamethasone.
How effective is Ninlaro?
Clinical trials have shown that Ninlaro is more effective than the medicines it was trialed against, in treating multiple myeloma.
- Ninlaro was faster at getting a response than the other treatment group in the clinical trial.
- Ninlaro delayed the progression of the illness longer than the other treatment group.
- Patients who trialled Ninlaro had a higher level of positive responses compared to other treatment group
- Ninlaro worked very well in high risk cytogenetic patients, patients with stage III illness and patients older than 75 years old
How long does it take to get a first response from treatment?
Time for response was faster in the Ninlaro group compared to the placebo group.
- The Ninlaro group took 1.1 month to get a response and the placebo group response took 1.9 months.
| Ninlaro Treatment Group (median) | Placebo treatment Group (median) | Difference Between Groups (median) | |
|---|---|---|---|
| Time for response | 1.1 month | 1.9 months | 0.8 month (approx 24 days) faster response for Ninlaro group |
Time to first progression of Multiple Myeloma
Ninlaro treatment was more effective at delaying the progression of multiple myeloma compared to the placebo group. The time delay to first progression in the Ninlaro group was:
- 5.9 months longer compared to the placebo group. (Ninlaro 20.6, placebo was 14.7)
- 11.7 months longer for high risk cytogenetics patients. (Ninlaro 21.4 months, placebo 9.7 months)
- 8.3 months in patients with stage III of the disease. (Ninlaro 18.4 months, placebo 10.1 months)
- 5.4 months in patients who are older than 75 years of age. (Ninlaro 18.5 months, placebo 13.1 months)
| Time delay to first progression of illness (median) | Ninlaro Treatment Group (median) | Placebo treatment Group (median) | Difference Between Groups (delay to first progression of illness median ) |
|---|---|---|---|
| All patients | 20.6 months | 14.7 months | 5.9 months longer delay in Ninlaro group |
| High risk cytogenetic patients | 21.4 months | 9.7 months | 11.7 months longer delay in Ninlaro group |
| Patients with stage III disease | 18.4 months | 10.1 months | 8.3 months longer delay in Ninlaro group |
| Patients older than 75 years old | 18.5 months | 13.1 months | 5.4 months months longer delay in Ninlaro group |
Patients had a higher positive response to treatment
Positive response to treatment was a higher in the Ninlaro group compared to placebo group
- Ninlaro group had a 78% positive response rate compared to 72% for the placebo group.
Level of positive response to treatment
How well someone responds to treatment can be divided into four levels.
The best level is complete response, then very good partial response, partial response and then no response (or relapse of illness) which is the worst response.
The Ninlaro group had the best levels of response compared to placebo
- Complete response: Ninlaro group was 5% higher than placebo group (Ninlaro 12%, placebo 7%)
- Very good partial response: Ninlaro group was 4% higher than placebo group (Ninlaro 36%, placebo 32% .
- Partial response: Placebo group was 3% higher than Ninlaro group (Ninlaro 30%, placebo 33%)
- No response or MM relapse: Placebo group was 6 % higher than Ninlaro group (Ninlaro 22%, placebo 28%)
| Level of Positive Response to Treatment | Ninlaro Treatment Group | Placebo treatment Group | Difference Between Groups |
|---|---|---|---|
| Overall response rate | 78% | 72% | 6% more in responders in Ninlaro group |
| Complete response | 12% | 7% | 5% more patients in the Ninlaro group had a complete response |
| Very good partial response | 36% | 32% | 4% more in the Ninlaro group had very good partial response |
| Partial response | 30% | 33% | 3% more of the placebo group had a partial response |
| No response or relapse of MM | 22% | 28% | 6% more of the placebo group had no response or relapse |
Is Ninlaro (ixazomib) an approved medicine by the FDA?
- Yes, Ninlaro has been approved by the FDA for multiple myeloma in patients who have already tried one previous therapy.
- Ninlaro is to be used in combination with lenalidomide (Revlimid) and dexamethasone
Bottom line:
Ninlaro was more effective than the medicines it was trialed against, as it:
- gave a faster response
- delayed the progression of illness longer
- patients had a higher level of positive responses
- people that were high risk cytogenetic patients, patients with stage III illness and patients older than 75 years old, responded particularly well to Ninlaro compared to the medicines it was trialed against.
References
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