The recent Food and Drug Administration (FDA) accelerated approval of Talvey (talquetamab-tgvs) for patients with heavily pretreated multiple myeloma represents a new treatment option with improved responses, an expert said.
“There’s no better way than that, that I can say why this is (FDA approval) so important, because, literally, we’re taking patients who have exhausted all therapies and giving them a new lease on life. And that’s what we’re all here to do,” Dr. Ajai Chari, professor of clinical medicine and director of the myeloma program at the University of California, San Francisco, said in an interview with CURE®.
The FDA recently granted accelerated approval to Talvey for the treatment of adults with relapsed/refractory multiple myeloma who previously received four or more therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Chari mentioned how he saw firsthand how treatment of patients with pretreated relapsed/refractory multiple myeloma contributed to more durable responses.
“I recently moved from New York to San Francisco after having practiced in New York for 20 years. And one of the hardest parts was saying goodbye to patients,” he said. “And in that process, several patients — I remembered we had actually spoken about hospice because they had exhausted all therapies. And today, they’re in some of their deepest and most durable remissions that they’ve ever had since their myeloma journey began.”
Before Talvey was approved, patients with heavily pretreated multiple myeloma did not have many treatment options after they have exhausted other options like proteasome inhibitors, immunomodulatory agents and anti-CD38 antibodies. Now with Talvey and Elrexfio — another drug recently approved for this patient population — now there is “an increasing arsenal of great drugs for these patients,” Chari said.
In the MonumenTAL-1 trial, the findings from which this FDA approval was based on, there were several common side effects that occurred in 20% or more patients including cytokine release syndrome. According to the National Cancer Institute, cytokine release syndrome is common with some immunotherapies and is caused by a rapid release of cytokines (immune substances) into the blood from immune cells that have been impacted by the treatment. Signs of this side effects include nausea, fever, rash, headache, low blood pressure, rapid heartbeat and trouble breathing.
Although cytokine release syndrome is common, occurring in approximately 70% to 80% of patients, all instances of this side effect in the trial were low grade, making them manageable by the cancer team.
“To mitigate that, there’s premedications that are given like steroids, Benadryl and Tylenol,” Chari said. “(Talvey is given as) step-up doses, (so) you don’t get the full dose at one time; you get it gradually titrated up. And finally, there’s a requirement that patients need to be hospitalized for 48 hours after each dose.”
There were also some potential skin-related side effects associated with Talvey such as rashes, skin peeling from the hands and feet, and brittle nails. Chari noted that most of these side effects can be managed with topical creams and steroids, although the search continues for ways to manage brittle nails.
“We haven’t found the magic bullet,” he said. “We’ve tried nail hardening solutions (and) vitamin E oil. Good news is it’s not painful, but it’s cosmetically unpleasant. The nails look a little bit fragile.”
What Chari calls the “more challenging” side effect from Talvey is oral-related including dry mouth, loss of taste, difficulty swallowing, all of which can occur in approximately 70% of patients.
“We recommend (advice) like (using) artificial saliva, candies, keeping up with hydration to avoid weight loss from those things, doing high caloric shakes,” Chari noted. “So if (the patient is) not super enjoying the taste of something, this is (their) time to go crazy with the ice cream sundaes, blend those up, and add your powders and whatnot.”
Chari added that what is unique about Talvey is that very few severe infections occur as a result of treatment.
“If you’re an advanced myeloma patient, you’re going to have infections because myeloma paralyzes the immune system in and of itself,” he explained. “But some of the other therapies in this space, like other bispecifics, have an infection rate of 45%, what we call grade 3 and higher, which means serious infections require IV antibiotics, hospitalizations, etc. This is about 15% to 20%, which is kind of where most drugs have historically been.”
Chari emphasized the importance of cancer teams sharing potential side effects with their patients and how to manage them. But he also highlighted how reminding patients that the median time to response to Talvey is one month, meaning that patients may not experience side effects for a long period of time.
“We’re not asking people to have all of these side effects with no hope for benefit,” he said. “You’re going to see a drop in those proteins immediately. And then when you see that drop, you actually have some breathing room. I tell patients we can skip a dose of the drug, we can reduce the dose, we can reduce the frequency and you’ll feel better. And that seems to work.”
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