Takeda presents positive data from Clinical Trial evaluating Oral NINLARO

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Takeda

TAKEDA Pharmaceutical Company Limited today announced it will orally present the results of two studies at the 25th Congress of the European Hematology Association, EHA. Presentations are available online starting Friday, June 12, 2020, and include positive results from TOURMALINE-MM4, a Phase 3, randomized clinical trial evaluating the effect of single-agent oral NINLARO, ixazomib, as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation.

Takeda is also presenting key insights from the US MM-6 trial, which investigates the effectiveness and safety of an in-class transition to oral NINLARO in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients, who have previously received a parenteral bortezomib-based triplet induction therapy.

The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in progression-free survival, PFS, versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001).

This corresponds to a 34% reduction in risk of progression or death in patients treated with NINLARO. The safety profile of NINLARO was consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.

“There is a strong need for additional maintenance treatments for multiple myeloma, where currently approved options are limited,” said Meletios Dimopoulos, MD, University of Athens School of Medicine and principal investigator of the TOURMALINE-MM4 trial.

“Data from this Phase 3 clinical trial reinforce the role of proteasome inhibition as a maintenance therapy and suggest that longer duration of therapy can improve a response, in addition to extending it. These data could be highly impactful for those who currently have limited options, which is often the case with patients not eligible for a stem cell transplant.”

Key findings of the TOURMALINE-MM4 trial, to be presented by Dr. Dimopoulos include:

  • The trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in PFS in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). Median PFS for patients in the NINLARO arm was 17.4 months compared to 9.4 months in the placebo arm.

This corresponds to a 34.1% reduction in risk of progression or death in patients treated with NINLARO.

  • The secondary endpoint of overall survival (OS) is not yet mature and follow-up is ongoing.
  • The benefits of NINLARO maintenance were realized in the context of a well-tolerated safety profile and no adverse impact on patients’ quality of life.
  • The safety profile of NINLARO is consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.

o The most common treatment emergent adverse events (TEAEs) (with incidence ≥5% higher with ixazomib) were nausea, vomiting, diarrhea, rash, peripheral neuropathy (PN) and pyrexia.

Grade ≥3 TEAEs were experienced by 36.6% of patients receiving NINLARO versus 23.2% receiving placebo.

The rate of new primary malignancies was 5.2% versus 6.2% in the placebo arm.

Discontinuation of treatment due to TEAEs was low, at 12.9% in the NINLARO arm and 8% in the placebo arm.

The rate of on-study deaths was 2.6% in the NINLARO arm compared to 2.2% in the placebo arm.

Updated data from US MM-6 will also be presented orally at EHA. The trial revealed the in-class transition from treatment with parenteral bortezomib to a NINLARO-based treatment, taken by patients at home, allowed for prolonged proteasome inhibitor administration and resulted in an increase in overall response rate from 62% to 70% and an increase in complete response from 4% to 26%.

These data suggest promising efficacy without impacting patients’ quality of life. The safety profile of NINLARO treatment in this setting is favorable with no unexpected safety signals identified in US MM-6.

“The positive data from the Phase 3 trial evaluating NINLARO as a maintenance therapy in patients not eligible for stem cell transplantation showed significant improvement in progression-free survival,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda.

“Coupled with the US MM-6 trial results of in-class transition from parenteral to oral proteasome inhibitor, these data add to the body of evidence supporting NINLARO could be an effective, tolerable and convenient medicine for patients with multiple myeloma that allows for an increased duration of treatment with proteasome inhibitors resulting in better outcomes.”

NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed / refractory multiple myeloma in more than 65 countries.

– Jun. 14, 2020 @ 16:59 GMT |

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