November 4, 2019 — Oncology News & Updates
- Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
- Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda Advanced Head and Neck Cancers
- Discussing Costs of Genomic Testing with Patients
Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
Data from the phase 3 ADMIRAL clinical trial showed that treatment with gilteritinib (Xospata; Astellas) led to significantly longer overall survival and higher percentages of patients with remission compared with salvage chemotherapy in adult patients with FLT3 mutation–positive relapsed/refractory acute myeloid leukemia (AML). Details from the trial were published in the October 31, 2019, edition of the New England Journal of Medicine (Perl AE, et al. N Engl J Med. 2019;381:1728-1740).
In this phase 3 open-label, multicenter, randomized trial, investigators compared gilteritinib with salvage chemotherapy in 371 adult patients with AML and FLT3 mutations who were refractory to or who had relapsed after first-line therapy. Patients were randomized in a 2:1 ratio to receive gilteritinib (120 mg/day) or salvage chemotherapy. The median overall survival in the gilteritinib group was 9.3 months versus 5.6 months in the chemotherapy group (hazard ratio, 0.64; 95% confidence interval [CI], 0.49-0.83; P <.001). In addition, treatment with gilteritinib almost doubled the percentage of patients who achieved complete remission or complete remission with partial hematologic recovery versus salvage (34.0% vs 15.3%; 95% CI, 9.8-27.4).
Grade ≥3 adverse events and serious adverse events occurred less frequently in the gilteritinib group than in the chemotherapy group. The most common grade ≥3 adverse events in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).
In May 2019, the FDA approved a supplemental New Drug Application to update the product labeling for Xospata to include final analysis overall survival data from the ADMIRAL trial.
In a press release from Astellas, Alexander Perl, MD, Associate Professor, Hematology-Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, and the trial’s principal investigator, said, “These data show that in a very high-risk leukemia population, single agent FLT3-targeted therapy leads to superior clinical outcomes compared to salvage chemotherapy. This is an important result for patients who previously had quite limited treatment options.”
Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda Advanced Head and Neck Cancers
According to results of a global study led by researchers at Yale Cancer Center, New Haven, CT, treatment with the checkpoint inhibitor pembrolizumab (Keytruda; Merck) results in longer survival time for patients with recurrent or metastatic head and neck squamous-cell carcinomas (HSNCCs), which include cancers of the oral cavity, oropharynx, hypopharynx, and larynx. Details of this study were published in The Lancet on October 31, 2019 (Burtness B, et al. Lancet. October 31, 2019. Epub ahead of print).
Based on efficacy and safety outcomes from the KEYNOTE-048 clinical trial, the researchers concluded that pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1–positive recurrent or metastatic HNSCC.
KEYNOTE-048 was a randomized, phase 3, global clinical trial of patients with untreated incurable recurrent or metastatic HNSCC in 37 countries. Of the 882 patients enrolled, 301 received pembrolizumab alone, 281 received pembrolizumab plus chemotherapy, and 300 received cetuximab plus chemotherapy.
Primary end points were overall survival and progression-free survival in the intention-to-treat population. Pembrolizumab alone improved median survival to 14.9 months, compared with 10.7 months for cetuximab with chemotherapy (hazard ratio, 0.61; 95% confidence interval, 0.45-0.83; P = .0007).
Grade ≥3 adverse events occurred in 55% of patients in the pembrolizumab alone group, 85% of those in the pembrolizumab plus chemotherapy group, and 83% of those in the cetuximab plus chemotherapy group.
Adverse events led to death in 8% of patients in the pembrolizumab alone group, 12% of those in the pembrolizumab plus chemotherapy group, and 10% of those in the cetuximab plus chemotherapy group.
The study’s lead investigator, Barbara Burtness, MD, Professor, Medical Oncology; Disease Aligned Research Team Leader, Head and Neck Cancers Program; and Co-Leader, Developmental Therapeutics, Yale Cancer Center, New Haven, CT, said in a press release, “This research demonstrates that this checkpoint inhibitor, with or without chemotherapy, should be the first drug used for these types of cancers.”
Discussing Costs of Genomic Testing with Patients
A study co-authored by researchers from the American Cancer Society, the National Cancer Institute, and the National Institutes of Health, and published this week in the Journal of the National Cancer Institute, says that approximately 1 in 4 oncologists (23.7%) “never or rarely” discuss with patients the costs related to genomic testing and related treatments (Yabroff KR, et al. JNCD: Journal of the National Cancer Institute. 2019;djz173. Epub ahead of print).
As the use of genetic testing increases, and healthcare costs continue to rise, with patients paying more out-of-pocket expenses, patients need to be better informed about the additional financial responsibility they will bear for their care, noted the researchers. Financial toxicity has become a significant aspect of oncology treatment, which may cause patients to delay or forgo essential medical care. Genomic tests can be expensive and are not always covered by health insurance.
Discussions about expected costs of genomic testing and related treatments may inform treatment decision-making and help patients with cancer prepare for high expenses. However, little is known about how often oncologists discuss the costs of genomic testing and related treatment with their patients, or the factors that influence the physician’s decision to have these discussions.
The researchers identified 1220 US oncologists who reported discussing genomic testing with their patients and identified potentially modifiable factors associated with the frequency of cost discussions. Of those surveyed, 50% reported “often” discussing the likely costs of testing and related treatments, 26.3% said that they talked price “sometimes,” and 23.7% indicated that they “never or rarely” discussed costs when recommending genetic testing. They concluded that although oncologists “may not be the providers best suited for all discussions about the expected costs of care,” they can nevertheless “be responsible for ensuring that these conversations take place with a member of the care team within their practice.”
Intratumoral Administration of INT230-6 Improves Drug Diffusion and Uptake into Cancer Cells in Patients with Advanced Solid Tumors
A novel intratumoral chemotherapy agent delivered by direct injection permits the dispersion of cytotoxic drugs into cancer cells to eradicate tumors, according to data from a phase 1/2 trial of INT230-6 alone and in combination with pembrolizumab in patients with advanced solid tumors.
Cyclin-dependent kinases (CDKs) 4 and 6 are overactive in many human cancers, resulting in a loss of regulation of the G1 cell cycle restriction point and making malignant cells less responsive to normal growth controls.1,2 CDK4 and CDK6 CDKs are key regulators of cell proliferation.3 In many tumor types, CDK4 [ Read More ]