Immuno-Oncology

As new, innovative therapies with high price tags, such as chimeric antigen receptor (CAR) T-cell therapy, come to market, the US health system will have to start looking at different approaches for reimbursement, said Ted Okon, MBA, executive director of the Community Oncology Alliance.

A recent trial looked to compare the efficacy and safety of pembrolizumab (Keytruda) with the standard of care for the treatment of head and neck squamous cell carcinoma (SCC).

Earlier this week, the FDA granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Patients with advanced cutaneous melanoma who are responsive to nivolumab (Opdivo) have higher serum levels of soluble CD163 (sCD163) compared with nonresponders, according to the results of a recent study.

The Allen Institute for Immunology has partnered with several cancer institutions, including the Fred Hutchinson Cancer Research Center, with the primary goal of understanding the differences between a defective and healthy immune system to improve immune-based treatments.

While patient-reported outcomes don’t provide the whole story, they can provide insight into how chimeric antigen receptor (CAR) T-cell therapy changes a patient’s life, said Brian Koffman, MDCM, DCFP, DABFM, MS Ed, medical director, CLL Society.

A median 19-month follow-up of the JULIET trial—a single-arm, open-label, multicenter, global, pivotal phase 2 trial of the chimeric antigen receptor-T cell therapy tisagenlecleucel directed against CD19-expressing B cells—has found a 40% complete response and a manageable safety profile in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Researchers at the 60th American Society of Hematology Annual Meeting & Exposition presented long-term study results showing that high rates of minimal residual disease–negative complete response were sustained with a median duration of over 4 years among treatment-naïve patients with multiple myeloma.

This study assesses the value of novel immuno-oncology treatments to society.

While new therapies like chimeric antigen receptor (CAR) T-cell therapy, can have amazing results, the innovation of these treatments has outstripped the United States’ ability to pay for them, said Michael Kolodziej, MD, vice president and chief innovation officer at ADVI Health, Inc.

A multicenter retrospective study that evaluated the efficacy and safety of chimeric antigen receptor (CAR) T-cell treatment, axicabtagene ciloleucel (axi-cel; Yescarta), in a real-world setting found a similar response as well as toxicity compared with the ZUMA-1 clinical trial.

This week, the FDA approved larotrectinib, to be sold as Vitrakvi, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene infusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

CD7 gene-edited chimeric antigen receptor (CAR) T cells target CD7-positive acute myeloid leukemia (AML) cells while sparing myeloid and erythroid cells and minimizing toxicity, according to the results of a recent study.

After being treated for his chronic lymphocytic leukemia with chimeric antigen receptor (CAR) T-cell therapy, Brian Koffman, MDCM, DCFP, DABFM, MS Ed, medical director, CLL Society, is being followed for 15 years to better understand if there are any undiscovered adverse events that pop up and how durable the response is.

Earlier this month, Merck announced that the FDA approved its anti–PD-1 therapy, pembrolizumab (sold as Keytruda), for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

The addition of nivolumab to azacitidine led to significantly better overall response rate and overall survival compared with previous hypomethylating agent-based regimens in patients with relapsed acute myeloid leukemia (AML), according to the results of a recent phase 2 study.

Researchers from Massachusetts General Hospital and the Broad institute of MIT and Harvard recently identified specific states of cytotoxic CD8+ T cells that are associated with patient response to checkpoint immunotherapy for melanoma.

It has been good knowing that treatments he has had a hand in developing will give years of quality life to patients, where treatments only gave a few months before, explained James Allison, PhD, chair of the Department of Immunology, the Vivian L. Smith Distinguished Chair in Immunology, director of the Parker Institute for Cancer Research, executive director of the Immunotherapy Platform at MD Anderson Cancer Center, and 2018 Nobel Prize cowinner in Medicine.

Today, the FDA approved elotuzumab (Empliciti), an injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies.

The use of CTLA-4, PD-1, or a combination approach achieved high response rates and improved overall survival in patients with CDKN2A mutations with metastatic melanoma, based on the results of a study by Helgadottir et al.

Earlier this week, the FDA approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).

Gene-edited glypican-3 (GPC3)-targeted chimeric antigen receptor (CAR) T cells with deficient programmed death–1 have greater cytotoxicity compared with wild-type GPC3-targeted T cells in GPC3-positive hepatocellular carcinoma, based on results from a recent study.

A study published in JAMA Opthalmology has confirmed that PD-1 inhibitors, and nivolumab in particular, are effective in the treatment of metastatic conjunctival melanoma.

As a basic scientist, James Allison, PhD, didn’t always meet the patients who benefitted from treatments he discovered, but he did meet 1 woman who participated in one of the early trials of ipilimumab.

A phase 3 trial recently investigated if nanoparticle albumin-bound paclitaxel enhances the treatment of atezolizumab in unresectable locally advanced or metastatic triple-negative breast cancer.

Switchable chimeric antigen receptor (CAR) T cells with a switch directed towards human epidermal growth factor receptor 2 (HER2) in pancreatic ductal adenocarcinoma (PDAC) has similar efficacy as conventional HER2 CAR T cells while also having a greater control over treatment toxicities.

Last week, Bristol-Myers Squibb announced results from the phase 3 CheckMate -331 trial that investigated nivolumab (Opdivo) versus the current standard of care, chemotherapy, in the treatment of patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The trial found that nivolumab did not significantly increase overall survival compared with chemotherapy.

Last week, the FDA granted approval to immune checkpoint inhibitor cemiplimab-rwlc, to be sold as Libtayo, for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC), or in patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

The development of resistance to immunotherapy is poorly understood and is detrimental to patients who relapse on multiple lines of treatment. Transcriptional downregulation of class 1 human leukocyte antigen (HLA) may contribute to the developed resistance of immunotherapies, including checkpoint inhibitors, and warrants further investigation, according to a study published in Nature Communications.

James P. Allison, PhD, and Tasuku Honjo, MD, PhD, led the basic science experiments that showed the potential of checkpoint inhibitors, creating a fourth pillar in the treatment of cancer.