FDA Stops Lung Cancer Trial, CAR-T Cell Therapy Is Cost Effective, Novel Drug Slows Fibrosis


The year 2024 is now underway. After a busy 2023, we’re now looking back at some of the oncology headlines from the new year.

The year 2024 is now underway. After a busy 2023, we’re now looking back at some of the oncology headlines from the new year.

Notably, we have a clinical trial hold for a lung cancer drug, a trial that showed that a CAR-T cell therapy is cost-effective — though far from cheap — for lymphoma treatment, and a novel drug that’s showing promise for the treatment of myelofibrosis.

Topics Discussed:

  • 0:40 FDA puts lung cancer trial is put on clinical hold
  • 1:54 Breyanzi is a cost-effective treatment option for relapsed/refractory diffuse large B-cell lymphoma
  • 4:51 A novel agent decreases fibrosis in myelofibrosis

FDA Places Hold on Trial Evaluating TIL Therapy in NSCLC

The Food and Drug Administration placed a clinical hold on the ongoing IOV-LUN-202 trial, evaluating LN-145 TIL for patients with non-small cell lung cancer. With the clinical hold, new patients will not be able to enroll on the trial, and those who were previously treated will continue to be monitored.

The FDA placed the hold on the trial after the death of a patient. According to the FDA, the agency has the power to request that a trial be stopped, and then the sponsor — that’s the organization or company running the study — can reply via a response letter addressing the concerns. The FDA then has 30 days to respond, and potentially allow for the trial to resume.

Breyanzi Cost Effective As Second-Line R/R DLBCL Treatment

Research published in the journal, Blood Advances, found that the CAR-T cell therapy, Breyanzi, was found to be a promising and cost-effective treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma — also known as DLBCL.

The study found that the incremental cost-effective ratio of the drug was just over $99,000 per quality-adjusted life-year from a health care perspective, and just over $68,000 from a societal perspective. Both these numbers are lower than the assumed social willingness to pay up to $100,000 per quality-adjusted life-year gained, as established by the American Society of Hematology.

While Breyanzi was deemed to be cost effective, CAR-T cell therapies are still far from inexpensive. In fact, the drug cost rose by 9% since its initial approval for DLBCL in 2022. In a CURE® Speaking Out® video series, Lee Greenberger, the chief scientific officer of the Leukemia & Lymphoma Society, expressed concern about the price of these drugs.

“Some of that the government is going to have to pay, some insurance is going to have to pay, but some of it the patients are going to have to pay as well. And the price tags are going to be significant. How are we going to manage that?

Phase 2 Trial Shows Fibrosis Reduction in Some With Myelofibrosis

Also in the blood cancer space, findings from the phase 2a trial found that a novel drug, GB2064, reduced fibrosis in the bone marrow, thereby slowing cancer progression in patients with myelofibrosis who were previously treated with Jakafi.

Myelofibrosis is a disease that affects the body’s production of blood cells in the bone marrow. The disease causes scar tissue to grow there — a process called fibrosis. By decreasing the amount of fibrosis that occurs, GB2064 has the potential to improve outcomes for this patient population.

However, we should note that this trial was completed in only a small number of patients — 10, to be exact. Six patients had a decrease of fibrosis after receiving GB2064 for six months.

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