With over 7,000 abstracts accepted at this year’s ASH annual meeting, how is a doctor or patient to know which trials have the highest potential impact on clinical practice?
Fortunately, through a rigorous peer-review process, the scientific leaders select “high impact” abstracts to be presented at the greatly anticipated Late Breaking Abstract Session and the “top six” abstracts to be presented during the prestigious, Plenary Scientific Session.
This year, both the PERSEUS Trial and IsKia Trial were showcased as critically important research that many myeloma experts have described as “practice changing.”
These trials add to the growing body of evidence and expert opinion, that suggest the time is now to recognize “quadruplet therapy” as a standard of care for newly diagnosed, transplant-eligible myeloma patients.
On Tuesday, December 11th Dr. Pieter Sonneveld, presented the primary analysis of the phase 3 PERSEUS Trial to a packed hall during the Late Breaking Abstract Session.
After the presentation, noted myeloma experts posted enthusiastic comments online.
Dr. Noopur Raje from Massachusetts General Hospital posted, “Unprecedented results with quad upfront as shown in PERSEUS study…a new standard of care.”
Dr. Rafael Fonseca from Mayo Clinic posted, “History in the making…superb results…”.
Dr. Nizar Bahlis from the University of Calgary posted, “Triumph of science and research.”
As further evidence of the significance of this research, after the presentation, Dr. Sonneveld announced that the trial was published simultaneously in the prestigious, New England Journal of Medicine. (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma | NEJM)
Patients in the quadruplet arm of DARA [daratumumab subcutaneous] plus VRD [Velcade, Revlimid, dexamethasone] followed by daratumumab + Revlimid maintenance had an impressive 84.3% progression-free survival (PFS) at 48 months. This means that 84.3% did not experience relapse or progression of their disease for 4 years!
This study also provides valuable insight regarding “response-guided therapy” during maintenance. 64% of patients who received daratumumab + Revlimid maintenance for at least two years were able to stop daratumumab after achieving MRD negative for longer than a year.
On Sunday, December 10th, the IsKia trial was presented by Dr. Francesca Gay from the University of Torino, Italy, during the Plenary Scientific Session.
302 patients were randomized to receive the treatment combinations of Kyprolis(K); Revlimid(R), Dexamethasone(d), and/or Isatuximab(Isa) as outlined below. The brand name of Isa is Sarclisa. MRD assessment was done after induction, transplant, and twice during consolidation. Patient characteristics were well-balanced between the treatment groups.
The primary endpoint was MRD negativity at the 105 level following post-transplant consolidation. The secondary endpoints include MRD negativity after induction, progression-free survival (PFS), and sustained MRD negativity.
The authors concluded the quadruplet combination of isatuximab (isa) plus KRd [carflizomib, revlimid, dexamethasone], performed significantly better than the triplet combination of KRd when looking for any myeloma cells at the 105 level (1 in 100,000) or 106 level (1 in 1,000,000). The addition of isatuximab did not add any safety profile risks to the combination. This benefit was also shown in the high-risk myeloma patient population in the trial.
The results of the IsKia trial provide further evidence of the potential value of quadruplet therapy in transplant-eligible, newly diagnosed myeloma patients.
Newly diagnosed myeloma patients who are eligible for transplant will want to consider the following points:
Based on the compelling results from PERSEUS and IsKia, it is unsurprising that these trials received high praise and accolades from the ASH scientific review committee and myeloma experts.
The results of these trials are reason to celebrate and have significant hope. Hope alone, however, is not enough. Since it can take time for the latest evidence to spread throughout academic and community practices, patients are encouraged to get educated and become empowered.
If you or someone you care for has been newly diagnosed, consider asking your doctor whether pivotal research, including PERSEUS and IsKia, is relevant to your specific case and if it is appropriate to incorporate these new insights into your personalized treatment strategy.
Would you like to watch ASH 2023 myeloma research interviews from the investigators themselves? Click "ASH 2023" here: HealthTree University Conference Coverage
To read other ASH 2023 articles, click here: HealthTree 2023 ASH Articles
With over 7,000 abstracts accepted at this year’s ASH annual meeting, how is a doctor or patient to know which trials have the highest potential impact on clinical practice?
Fortunately, through a rigorous peer-review process, the scientific leaders select “high impact” abstracts to be presented at the greatly anticipated Late Breaking Abstract Session and the “top six” abstracts to be presented during the prestigious, Plenary Scientific Session.
This year, both the PERSEUS Trial and IsKia Trial were showcased as critically important research that many myeloma experts have described as “practice changing.”
These trials add to the growing body of evidence and expert opinion, that suggest the time is now to recognize “quadruplet therapy” as a standard of care for newly diagnosed, transplant-eligible myeloma patients.
On Tuesday, December 11th Dr. Pieter Sonneveld, presented the primary analysis of the phase 3 PERSEUS Trial to a packed hall during the Late Breaking Abstract Session.
After the presentation, noted myeloma experts posted enthusiastic comments online.
Dr. Noopur Raje from Massachusetts General Hospital posted, “Unprecedented results with quad upfront as shown in PERSEUS study…a new standard of care.”
Dr. Rafael Fonseca from Mayo Clinic posted, “History in the making…superb results…”.
Dr. Nizar Bahlis from the University of Calgary posted, “Triumph of science and research.”
As further evidence of the significance of this research, after the presentation, Dr. Sonneveld announced that the trial was published simultaneously in the prestigious, New England Journal of Medicine. (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma | NEJM)
Patients in the quadruplet arm of DARA [daratumumab subcutaneous] plus VRD [Velcade, Revlimid, dexamethasone] followed by daratumumab + Revlimid maintenance had an impressive 84.3% progression-free survival (PFS) at 48 months. This means that 84.3% did not experience relapse or progression of their disease for 4 years!
This study also provides valuable insight regarding “response-guided therapy” during maintenance. 64% of patients who received daratumumab + Revlimid maintenance for at least two years were able to stop daratumumab after achieving MRD negative for longer than a year.
On Sunday, December 10th, the IsKia trial was presented by Dr. Francesca Gay from the University of Torino, Italy, during the Plenary Scientific Session.
302 patients were randomized to receive the treatment combinations of Kyprolis(K); Revlimid(R), Dexamethasone(d), and/or Isatuximab(Isa) as outlined below. The brand name of Isa is Sarclisa. MRD assessment was done after induction, transplant, and twice during consolidation. Patient characteristics were well-balanced between the treatment groups.
The primary endpoint was MRD negativity at the 105 level following post-transplant consolidation. The secondary endpoints include MRD negativity after induction, progression-free survival (PFS), and sustained MRD negativity.
The authors concluded the quadruplet combination of isatuximab (isa) plus KRd [carflizomib, revlimid, dexamethasone], performed significantly better than the triplet combination of KRd when looking for any myeloma cells at the 105 level (1 in 100,000) or 106 level (1 in 1,000,000). The addition of isatuximab did not add any safety profile risks to the combination. This benefit was also shown in the high-risk myeloma patient population in the trial.
The results of the IsKia trial provide further evidence of the potential value of quadruplet therapy in transplant-eligible, newly diagnosed myeloma patients.
Newly diagnosed myeloma patients who are eligible for transplant will want to consider the following points:
Based on the compelling results from PERSEUS and IsKia, it is unsurprising that these trials received high praise and accolades from the ASH scientific review committee and myeloma experts.
The results of these trials are reason to celebrate and have significant hope. Hope alone, however, is not enough. Since it can take time for the latest evidence to spread throughout academic and community practices, patients are encouraged to get educated and become empowered.
If you or someone you care for has been newly diagnosed, consider asking your doctor whether pivotal research, including PERSEUS and IsKia, is relevant to your specific case and if it is appropriate to incorporate these new insights into your personalized treatment strategy.
Would you like to watch ASH 2023 myeloma research interviews from the investigators themselves? Click "ASH 2023" here: HealthTree University Conference Coverage
To read other ASH 2023 articles, click here: HealthTree 2023 ASH Articles
about the author
Todd Kennedy
Todd Kennedy was diagnosed with myeloma in 2017 and has become a tireless advocate for myeloma patients and research. His background includes over 30 years working in the pharmaceutical industry until he and his wife Diane retired from their respective first careers to devote their time and talents to strengthen the myeloma community. They collaborate with HealthTree and other trusted partners to educate and empower myeloma patients and caregivers and accelerate the arrival of cures.
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.