GI CANCERS

General Cancer

The investigational agent SM-88 demonstrated promising survival in the phase II TYME-88-Panc study in patients with advanced pancreatic cancer.^1,2&nbsp;The&nbsp;oral modified dysfunctional tyrosine induced a median overall survival of 6.4 months in patients.<br /> &nbsp;

The FDA has accepted 6 supplemental Biologics License Applications (sBLAs) for review for a potential update to the dosing schedule for pembrolizumab across several indications.

In an interview with <em>Targeted Oncology</em>, Shota Fukuoka, MD, PhD, of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, commented on the results of the study and the future plans to expand the research with a larger cohort.

Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with&nbsp;high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib.&nbsp;Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.&nbsp;

A prefilled syringe of&nbsp;lanreotide has been approved by the FDA to&nbsp;enable healthcare providers to administer the injection easier to adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report&nbsp;that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

A cohort of cancer centers was selected to serve as models for identifying key strategies for racial and ethnic minority group engagement in clinical trials. On the basis of several qualifying criteria, such as sustained accrual of minorities into clinical cancer research, an established minority population &ge;10% in the overall catchment, an established clinical trial infrastructure, and a formal community outreach program, the investigators identified 8 cancer centers for participation.

In a case-based-style discussion, Tanios S. Bekaii-Saab, MD, and Wells Messersmith, MD, reviewed the treatment of patients with colorectal cancer whose tumors express rare gene mutations or molecular signatures, such as <em>NTRK</em> fusions.

Radiolabeled somatostatin analogues, a form of peptide receptor radionuclide therapy, have gained clinical use in treating neuroendocrine tumors found in the midgut, the non-midgut, and the pancreas. NETs generally have high expression of somatostatin receptors, the target of somatostatin analogues. The most commonly used radionuclides, lutetium 177&nbsp;and yttrium 90&nbsp;are &beta; emitters.

ABP 980, a trastuzumab biosimilar, has been approved by the FDA&nbsp; for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

During a recent&nbsp;<em>Targeted Oncology&nbsp;</em>live case-based peer perspectives presentation, Tanios Bekaii-Saab, MD, discussed with a group of physicians the treatment options for patients with gastrointestinal cancers and the characteristics that influence his decision making. Bekaii-Saab explained his clinical decisions based on the case scenario of one patient with colorectal cancer and one with hepatocellular carcinoma.

<em>Targeted Oncology</em>&nbsp;spoke with experts in attendance at the 2019 ASCO Annual Meeting to review what they believed were some of the biggest takeaways from this year&#39;s presentation across the fields of lung cancer, breast cancer, GI cancers, genitourinary cancers, melanoma, and multiple myeloma.

A phase III trial has begun for the investigational agent pemigatinib in comparison with gemcitabine and cisplatin chemotherapy for the treatment of newly diagnosed patients with metastatic or surgically unresectable cholangiocarcinoma who have activating <em>FGFR2 </em>rearrangements. The first patient has already been treated with the selective FGFR inhibitor in the open-label, randomized FIGHT-302 trial, according to a press release from Incyte, the company developing the agent.

Patients with PD-L1&ndash;positive,&nbsp;HER2-negative, advanced gastric or gastroesophageal junction cancer had non-inferior overall survival with frontline pembrolizumab compared with standard chemotherapy,&nbsp;according to results from the phase III KEYNOTE-062 trial.

The novel bispecific antibody ZW25 has been granted a fast track designation by the FDA for the treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma to be used in combination with standard-of-care chemotherapy.

In an interview with&nbsp;<em>Targeted Oncology</em>, experts in gynecology, gastrointestinal, genitourinary, lung, and breast cancers spoke to the significance of the abstracts they are most looking forward to at the 2019 ASCO Annual Meeting.

Comparable efficacy and minimized adverse events were seen with a lower dose of&nbsp;oxaliplatin (Eloxatin) and capecitabine (Xeloda)&nbsp;in elderly and frail patients with advanced gastroesophageal cancer, according to findings to be presented during&nbsp;the 2019 American Society of Clinical Oncology Annual Meeting.

The FDA has granted P-BCMA-101 with an orphan drug designation for the treatment of patients with relapsed and/or refractory multiple myeloma.

Radioembolization is an&nbsp;effective treatment option for patients with neuroendocrine neoplasms and liver metastases, demonstrating a disease control rate of &gt;90% in an international, retrospective study.

Findings from a study of tumor samples collected from patients with pancreatic ductal adenocarcinoma revealed that 17% of tumors harbored a known genomic alteration for which targeted therapies have already been developed, conferring feasibility to implementing precision medicine in a disease that has seen little progress in the development of effective therapeutic agents.

A new phase III trial has demonstrated that a novel extended-release formulation of anagrelide (Thromboreductin) is noninferior to immediate-release anagrelide in reducing platelet counts in patients with essential thrombocythemia.