On August 15, 2024, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi^®) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adults with resectable (tumors that are 4 cm or larger or node positive) non-small cell lung cancer and no known epidermal growth factor receptor variants or anaplastic lymphoma kinase rearrangements.

On August 2, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to afamitresgene autoleucel (Tecelra^®), a melanoma-associated antigen A4 (MAGE-A4)–directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or -cleared companion diagnostic devices.

On July 30, 2024, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro^®) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantations.

Mrs. Brown (she/her) is a 70-year-old assigned female at birth with a history of diffuse large B-cell lymphoma with central nervous system involvement. She received axicabtagene ciloleucel and tolerated the immune effector cell infusion.

Study participants with clear-cell renal cell carcinoma who received pembrolizumab after surgery had nearly 40% increased overall survival during the first four years after treatment, researchers reported in the New England Journal of Medicine.

On June 26, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp (Epkinly^™), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On February 16, 2024, the U.S. Food and Drug Administration approved the first tumor-infiltrating lymphocyte cancer therapy for metastatic melanoma, lifileucel (Amtagvi™). Patients in the drug’s clinical trial experienced a significant decrease in tumor burden, and the median overall survival was 17.4 months.

On May 30, 2024, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi^®) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

On May 15, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (Breyanzi^®) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

This ONS resource was produced for educational purposes only. Refer to the full elranatamab-bcmm (Elrexfio™) package insert for all details.

Since the first bispecific antibody (BsAb), blinatumomab, received U.S. Food and Drug Administration approval in 2014, the drug class has developed exponentially, with the majority of currently approved agents entering clinical practice in the past two years. BsAbs are very effective for treating certain malignancies, including multiple myeloma and leukemia, and most are approved for oncology indications. Here’s what makes BsAbs different than other cancer treatments and the key considerations for oncology nursing clinical practice.

On March 6, 2024, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo^®) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

This ONS resource was produced for educational purposes only. Refer to the full talquetamab-tgvs (Talvey™) package insert for all details. 

Nivolumab with chemotherapy and pembrolizumab with enfortumab vedotin-ejfv, an antibody-drug conjugate, are superior to standard chemotherapy as initial treatment for patients with advanced bladder cancer, researchers reported in study results from the Checkmate-901 and EV-302 clinical trials. The studies represent major strides in treatment for advanced bladder cancer, which has not seen changes in standard initial therapy for many years.

On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.

Cellular therapy has revolutionized cancer treatments and outcomes for many patients, and it may one day revolutionize the management of certain side effects as well. According to study findings published in eBioMedicine, induced pluripotent stem cell transplantation may help reverse chemotherapy’s endocrine and reproductive effects on female infertility. 

Growing evidence suggests that the gut microbiome, a diverse and complex mix of microorganisms and their metabolites, is closely linked to the immune system, and researchers are studying whether modulating the gut microbiome affects cancer immunotherapy treatment outcomes. In particular, probiotics—which are flora typically obtained through dietary sources such as yogurt and fermented foods or via supplemental forms—are gaining prominence as a potential strategy to modulate the gut microbiome during cancer treatment.

More than two-thirds of patients with hormone receptor–positive metastatic breast cancer respond to personalized immunotherapy with tumor-infiltrating lymphocytes and more than half of those treated experience measurable tumor shrinkage, according to study findings published in the Journal of Clinical Oncology.

Combination treatment with an oncolytic virus plus a PD-1 inhibitor shows promise in patients with nonmelanoma skin cancers, researchers reported in early study results during the 2022 Multidisciplinary Head and Neck Cancers Symposium.

Rapid advancements in the science of chimeric antigen receptor (CAR) T-cell therapies present unique challenges and opportunities related to patient care. Nurses are at the forefront of those advancements—contributing to practice guidelines, developing center-specific protocols, publishing outcomes and best practices, and researching the patient experience, outcomes, and supportive interventions.

The interprofessional team for chimeric antigen receptor (CAR) T-cell therapy at Smilow Cancer Center at Yale New Haven includes a transplant team, cell collection and processing unit, intensive care unit, pharmacy, telehealth for home evaluations, and social work. On that team, the oncology clinical social worker’s role is chiefly to help patients and families manage the stress associated with therapy. We provide patients and family members with ongoing clinical social work support, including listening, counseling, educating, advocating, and referring them to resources and services.

Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.

Initial treatment with two monoclonal antibodies significantly improves survival for patients with BRAF V600-variant advanced melanoma compared to treatment with two targeted agents, researchers reported during the November 2021 ASCO Plenary Series meeting. The initial findings were so conclusive that the study’s data safety and monitoring board stopped the trial early.

Patients with melanoma who consume a high-fiber diet during treatment with immune checkpoint inhibitors (ICIs) or anti-PD-1 therapy experience longer progression-free survival than those who don’t, researchers reported in Science. And probiotic supplementation, often considered a healthy behavior, reduces immunotherapy response.

Before immunotherapies like immune checkpoint inhibitors (ICIs) became a cancer treatment option, myocarditis typically developed in the presence of infections, drug allergies, or autoimmune diseases. Activating the immune system with ICIs can also trigger autoimmune-like adverse events such as myocarditis, and although its incidence in patients with cancer is low, mortality is high.

Completing up to a year of pembrolizumab immunotherapy after surgical resection of stage IIB or IIC melanoma decreases patients’ risk for disease recurrence or death by 35%, according to study findings presented at the European Society for Medical Oncology 2021 annual meeting. The new findings led the U.S. Food and Drug Administration to expand its approval of pembrolizumab to use as adjuvant therapy in both adults and children aged 12 and older with early-stage melanoma.

Immune checkpoint inhibitors (ICIs) enhance immune response against foreign antigens, such as cancer, by manipulating checkpoints that have stopped the body from fighting them. In doing so, they also increase risk of the immune system attacking healthy cells and producing inflammatory side effects, resulting in immune-related adverse events (irAEs).

Immunotherapy has revolutionized cancer treatment, especially for patients with diseases considered otherwise incurable. Since May 2017, the U.S. Food and Drug Administration (FDA) has approved 27 immunotherapy combinations, including chemoimmunotherapy and regimens with targeted therapies, and researchers are reporting highly promising data from clinical trials of its combination with radiation.

Using two agents that target two different receptors more than doubles length of survival for advanced melanoma than a single agent alone, researchers reported at the 2021 American Society of Clinical Oncology annual meeting.

Using antibiotics during treatment with immune checkpoint inhibitors may limit the therapy’s effect, according to study results published in the American Journal of Clinical Oncology.

Evolution may be the key to understanding immunity—or at least the National Institutes of Health (NIH) thinks so. Studies of the history of human life could uncover discoveries that have implications for all types of disease, including cancer.

Scientists created a new cancer immunotherapy approach that uses a new type of CAR T cells to stimulate an immune response against cells that are missing one gene copy. They reported their findings in Proceedings of the National Academy of Sciences.

Randi is a 57-year-old patient who identifies as female. She was diagnosed with clear cell metastatic renal cell carcinoma (mRCC), and her past medical history includes mild hypertension managed with amlodipine and a two-year history of transient musculoskeletal pain managed with tramadol. She reports a family history of cardiovascular disease and rheumatoid arthritis (RA). Her primary care physician suspects Randi is at the beginning stages of fibromyalgia but has not made a conclusive diagnosis because she hasn’t experienced additional symptoms.

Patients with uveal melanoma who were treated with tebentafusp, an investigational immunotherapy, lived a median 5.7 months longer than those in comparison groups, researchers reported in study findings presented at the American Association for Cancer Research 2021 annual meeting. 

Altering a patient's gut microbiome through fecal transplant improved response to immune checkpoint inhibitor therapy in 40% of patients with advanced melanoma who initially did not respond to the immunotherapy in a small, single-arm clinical trial. Researchers reported the findings in Science.

Patients with higher muscle quality during treatment with PD-1/PD-L1 inhibitor monotherapy for non-small cell lung cancer (NSCLC) had higher overall response rates and longer progression-free survival than patients with lower-quality skeletal muscle, researchers reported in study findings published in Cancer Medicine.

Starting immunotherapy for bladder cancer shortly after initial treatment with chemotherapy is better than taking an extended break from cancer treatment, according to results from a study reported at the American Society of Clinical Oncology annual meeting.

Combination immunotherapy treatments are revolutionizing the way cancer care is delivered. As an ongoing evolution of care, nurses are administering different treatment modalities on a regular basis. Treatments include using multiple immunotherapy drugs in tandem, combining chemotherapy with immunotherapy, using targeted therapies with immunotherapy, and even involving radiation with immunotherapy. The move toward multiple-drug modalities will continue to change nursing practice, and nurses must have a basis of knowledge and evidence from which to work.

A new type of remodeled CAR T-cell treatment is just as effective as the original therapy but may result in fewer neurologic side effects, researchers reported in Nature Medicine.

The abscopal effect is a unique phenomenon in cancer treatment that occurs when radiation shrinks untreated tumors found elsewhere in the body in addition to the targeted tumor. The effect has a long history, dating back to the 1950s, but it doesn’t commonly occur in practice and the mechanisms are not fully understood. Research has shown that combining immunotherapy with radiation increases the rate at which the abscopal effect occurs. Understanding how it appears in practice could potentially lead to new cancer treatments and a novel approach to combining immunotherapies with radiation.

Immunotherapies have revolutionized the approach to cancer treatment by leveraging patients’ own immune systems to fight the disease. But the novel therapies have also brought an evolution in traditional treatment regimens through their combination with chemotherapy, radiation, targeted therapy, or even other immunotherapy drugs.

Three years ago, Sarah, age 54, completed standard chemotherapy and radiation treatment for stage II, ER- and PR-positive, HER2-negative invasive breast cancer. A recent computed tomography scan, ordered to evaluate persistent hip pain, revealed bone lesions, and a biopsy and positron-emission tomography scan confirmed bone-only metastatic breast cancer. A CDK4/6 inhibitor, ribociclib, was added to the letrozole she was already taking.

Children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia reported rapid improvements in quality of life (QOL) after treatment with tisagenlecleucel, a CAR T-cell therapy, according to the results of a study published in Lancet Oncology.

Receiving antibiotics in the 30 days prior to starting immune checkpoint inhibitor treatment was associated with significantly reduced median overall survival, according to findings from a study published in JAMA Oncology. However, antibiotic use during treatment had no effect on survival.