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Multiple Myeloma an incurable disease, but I have spent the last 25 years in remission using a blend of conventional oncology and evidence-based nutrition, supplementation, and lifestyle therapies from peer-reviewed studies that your oncologist probably hasn't told you about.
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- Teclistamab for Myeloma- Risk of Death?
Teclistamab for Myeloma- Risk of Death?
I want to begin this post by saying that risk of death is an ever present reality for myeloma survivors in general not to mention myeloma patients who have relapsed 4 times. Once you’ve been told that you have an incurable cancer, life is more about when and not if.
Further, I have witnessed more than a dozen FDA approvals since my original diagnosis in 1994. Approvals of both single myeloma chemotherapy regimens as well as a variety of chemo cocktails that have benefited myeloma patients of all ages and stages.
The issue discussed in the linked and excerpted article below then, is not that a new chemo regimen was given FDA “accelerated approval” and that 6% of patients died in the trial. The issue is the end-point.
By relying on MRD negative as the end-point of studies, conventional oncology is doing exactly what Dr. Vincent Rajkumar talks about in his essay Treatment of Myeloma: The Cure vs. Control Debate.
That is to say that oncology is giving myeloma patients aggressive therapies with the goal of trying to cure myeloma patients. Or perhaps I should say that aggressive doses of highly toxic therapies are being tested.
In the article below, Dr. Munshi states that overall survival has “gone up to 10-15 years.” While there are a growing percentage of myeloma patients who live for 10 years or more, The five-year average for myeloma patients is 55%. Ten year life expectancies are not the norm.
If quality-of-life had equal standing as quantity-of-life, would the doses being tested be smaller? Would the test subjects be given an anti-angiogenic or anti-inflammatory diet/supplementation while they were given the test therapy?
If a new therapy like Teclistamab was being trialed would it be possible to reduce the dose being tested with the goal being simply to control the myeloma patient’s disease and not try to cure him or her?
I believe that myeloma patients and survivors should be the ones who decide about a new therapy that has a substantial risk of death or comes with an increased risk of serious adverse events aka side effects.
It seems to me that the myeloma survivor who has relapsed 4 plus times has probably lived with many short, long-term and late stage side effects and therefore is the person who should decide about his/her risk of death.
I have researched and written about death and the myeloma survivor many times.
- Multiple Myeloma End-Stage, Hospitalization, Death
- End Stage Multiple Myeloma- Then Death
- Multiple Myeloma- End-stage Running out of Options
- Lesions Increase Risk of Death in Myeloma
- Cancer Therapy + Cardiotoxicity = Heart Damage, Death
- Heart Failure + Surgery = Higher Risk of Death
- Multiple Myeloma: Preventing Myeloma-related Death
Scroll down the page to post a question or comment.
thank you,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Teclistamab for MM: Lifesaver or ‘Cause of Death’?
“Following “unprecedented” results in a phase 1/2 study, teclistamab received accelerated approval from the Food and Drug Administration for adults with relapsed/refractory multiple myeloma who had received at least four lines of therapy. Typically, patients in this situation have just a few weeks to live. The nod from the FDA on Oct. 25 for teclistamab, the first bispecific B-cell maturation antigen–directed CD3 T-cell engager to be approved, was based on data from a phase 1/2 study called MagesTEC-1 (NCT03145181; NCT04557098).
Patients in the study showed an overall response rate of 61.8%, and 26.7% of people in the study had no detectable disease (MRD neg.)…
“Pomalidomide got approved with 30% response rate, carfilzomib got approved with 29% response rate, selinexor got approved with 31% response rate and so on and on. … So here is teclistamab with [this] response rate in patients having five, six lines of treatment…”
At the 6-month mark,
- 90.6% of patients who responded had no progression of their disease,
- and at 9 months, 66.5% of patients were still holding steady…
Usmani contrasted this regimen with that of chimeric antigen receptor (CAR) T-cell therapy, the only alternative with similar efficacy in such sick patients: “I can prescribe [teclistamab] today, and my patient gets it tomorrow,” Usmani said. “With CAR T, I prescribe today and it will take 4-6 weeks for us to collect T cells and another 6-7 weeks for the product to come back.” Usmani said many patients die before CAR T reaches them…
Patel said, “Phase 1 plus phase 2 data is probably a little bit quick, but time will tell eventually.” He cited melflufen as a cautionary tale: a product given accelerated approval for multiple myeloma, then withdrawn when new data showed that it increased the risk of death…
Munshi went on to say that overall survival (OS) is no longer a viable trial endpoint in diseases like multiple myeloma for several reasons. Most significantly, he noted: “Survival has gone up to 10 or 15 years [so] today, if you randomize between one [drug] versus another, there are going to be seven or eight more treatments before the patient dies.”
Similarly, progression-free survival (PFS) in multiple myeloma is now as much as 5 years, Munshi said. “Do we want a patient to wait 5 years to get a very good new drug?…”
For these reasons and others, Munshi observed, myeloma researchers are increasingly relying on a surrogate called “negative minimal residual disease” (negative MRD) – in other words, a situation in which myeloma cells can no longer be detected in the bone marrow…
Munshi stressed that such patients are not necessarily “cured.” It will take a few more years to prove that. He noted: “Simply, physiologically, [negative MRD] means that if a patient has one [myeloma] cell in a million, that cell is going to take a much longer time to grow up to be myeloma…”
Chari said that, for his part, he wanted to see more transparency around “cause of death” in all studies that lead to accelerated approvals. He said he was “tired” of seeing a death labeled as “not attributed” to the drug by the investigator or the drug company.
“Let me decide. Show me the deaths, and show me the myeloma status at that point,” Chari said. “That’s a signal – if you’re a responding patient and dying, then the FDA should be a little bit more cautious.”
The FDA has added a boxed warning to the teclistamab product information concerning cytokine-release syndrome and neurologic toxicity.
Cytokine-release syndrome, the most common side effect overall, showed up in 72% of patients, typically 2 days after the first step-up dose.
Neurologic toxicity occurred in 57% of patients, including headache (25%), motor dysfunction (16%), sensory neuropathy (15%) and encephalopathy (13%). About 6%of patients developed a serious, life-threatening neurologic condition called immune effector cell–associated neurotoxicity syndrome…”