GIST

Based on findings from the phase I/II NivoRam study, investigators at the 2019 Gastrointestinal Cancers Symposium reported that the combination of nivolumab and ramucirumab is active in patients with previously treated advanced gastric adenocarcinoma.

In findings reported at the 2019 Gastrointestinal Cancers Symposium, 67% of patients with untreated metastatic HER2-positive esophagogastric adenocarcinoma treated with the combination of pembrolizumab, trastuzumab, and chemotherapy remained progression-free at 6 months.

According to findings from the KEYNOTE-181 trial, pembrolizumab demonstrated a significant improvement in overall survival in patients with PD-L1–positive advanced or metastatic esophageal or esophageal junction carcinoma who progressed on standard therapy, marking the first time a PD-1 inhibitor has demonstrated a survival improvement in this patient population.

ASLAN Pharmaceuticals, the company developing varlitinib (ASLAN001), has announced that a phase II frontline trial investigating the pan-HER inhibitor added to mFOLFOX6 in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer has missed its primary endpoint.

Cathy Eng, MD, discusses the current paradigm of GI cancers, specifically sharing insight on colorectal cancer and hepatocellular carcinoma.<br /> &nbsp;

The FDA has granted an&nbsp;accelerated approval to larotrectinib (Vitrakvi)&nbsp;for use in adult and pediatric patients with solid tumors that have an <em>NTRK</em> gene fusion 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.

Avapritinib showed substantial clinical activity in patients with gastrointestinal stromal tumors with <em>KIT</em> and <em>PDGFRA</em> mutations, according to findings from the phase I NAVIGATOR trial presented at the 2018 CTOS Annual Meeting. To date, patients with GIST who harbor these mutations have typically been resistant to all available therapies.

The investigational agent avapritinib demonstrated encouraging response rates in patients with advanced gastrointestinal stromal tumors and PDGFR&alpha; D842V-driven GIST, according to findings presented during the 2018 Annual Meeting of the Connective Tissue Oncology Society in Rome, Italy.

During the 2018 Annual Meeting of the Connective Tissue Oncology Society, Anette Duensing, MD, assistant professor of pathology at University of Pittsburgh, discusses the need for further investigation into how treatment type impacts perceived cognitive function in patients with gastrointestinal stromal tumor.

Anthony F. Shields, MD, PhD, discusses pivotal data from the IDEA pooled analysis, consisting of 6 international, noninferiority, phase III colon cancer studies.

Al B. Benson III, MD, FACP, FASCO,&nbsp;discusses the treatment landscape for advanced and metastatic CRC and how molecular profiling can play a vital role in selecting the optimal treatment plan for each patient. He also emphasizes the importance of participation in clinical trials to further understand these patients.

In a presentation at the 2018 International Society of Gastrointestinal Oncology Annual Meeting, Yung-Jue Bang, MD, PhD, discusses the most promising biomarkers and treatment approaches for patients with GEJ cancer, highlighting recent and ongoing trials of immunotherapy.

Milind Javle, MD, discusses findings with the selective pan-FGFR kinase infigratinib in patients with intrahepatic cholangiocarcinoma and how they highlight&nbsp;the role of molecular profiling.

Ben George, MD,&nbsp;discusses the findings from the phase III TAGS study and how these data can impact the treatment landscape of metastatic gastric cancers.

Based on data from the&nbsp;phase III TAGS trial,&nbsp;a supplemental new drug application seeking approval for TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf)&nbsp;for use in previously treated patients with advanced or metastatic gastric adenocarcinoma,&nbsp;including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.

Olaparib (Lynparza) has been granted an&nbsp;orphan drug designation by the FDA for the treatment of patients with pancreatic cancer,&nbsp;AstraZeneca and Merck, the developers of the PARP inhibitor, have announced.

The first patient has been dosed in the phase III FIGHT trial investigating bemarituzumab (FPA144) combined with chemotherapy in patients with previously untreated advanced gastric or gastroesophageal junction cancer, according to Five Prime Therapeutics, the developer of the isoform-selective FGF receptor 2b antibody.

Tanios Bekaii-Saab, MD,&nbsp;shares his insights on the results from the ReDOS trial, as well as the IMblaze370 trial for patients with mCRC

Cathy Eng, MD, discusses recent data that could shape the treatment landscape for several GI cancers.

According to findings from the CheckMate-032 trial, clinically meaningful and durable antitumor activity was found with nivolumab (Opdivo) alone and nivolumab plus ipilimumab in heavily-pretreated patients with esophagogastric cancer.

No one doubts that molecular testing has rapidly improved care for patients with colorectal cancer, Stanley R. Hamilton, MD, told his audience at the 2nd Annual International Congress on&nbsp;Oncology Pathology.

Results from a prospective study involving 15,045 tumor samples that underwent next-generation sequencing using MSK-IMPACT and microsatellite-instability testing demonstrate that MSI-high and DNA mismatch-repair deficient tumors are predictive of Lynch syndrome across all tumor types. The results suggest that LS-associated cancers may be more heterogeneous than previously suspected.

Lenvatinib (Lenvima) has been granted approval by the FDA&nbsp;as a first-line treatment for patients with unresectable hepatocellular carcinoma,&nbsp;based on data from the phase III REFLECT trial.

John L. Marshall, MD, chief of the&nbsp; Division of Hematology/Oncology at Medstar Georgetown University Hospital, Otto J. Ruesch Center for the Cure of Gastrointestinal Cancer, discusses the use of chemotherapy in patients with colorectal or other gastrointestinal cancers. He also highlights the importance of understanding each individual patient&rsquo;s needs before making a treatment decision.&nbsp;

The triplet combination of&nbsp;the BRAF inhibitor encorafenib, the MEK inhibitor binimetinib, and the EGFR inhibitor cetuximab has been granted a breakthrough therapy designation by the FDA for the&nbsp;treatment of patients with <em>BRAF</em> V600E&ndash;mutant metastatic colorectal cancer following 1 or 2 prior lines of treatment in the metastatic setting.&nbsp;The designation will expedite the development and review of the novel triplet in this setting.

Compared with sorafenib (Nexavar) alone, sorafenib in combination with selective internal radiation therapy did not provide a significant survival improvement for patients with&nbsp;advanced hepatocellular carcinoma,&nbsp;according to results from the palliative cohort of the SORAMIC trial presented at the 2018 World Congress on Gastrointestinal Cancer in Barcelona, Spain. However, overall survival improvements were seen with the combination in select subgroup analyses.

The Gene Upshaw Memorial Tahoe Forest Cancer Center has established a cancer care model to address disparities in lung cancer in rural areas. By partnering with the UC Davis Comprehensive Cancer Center and their UC Davis Cancer Care Network, they have been able to address a large issue in cancer care, where 20% of the American population is living in a rural area without access to a National Cancer Institute-designated cancer center.

The European Union has approved&nbsp;PF-05280014 (Trazimera), a biosimilar for trastuzumab (Herceptin), to treat&nbsp;patients with HER2 overexpressing metastatic or early breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA issued several approvals in July, including in colorectal cancer, breast cancer, prostate cancer, and acute myeloid leukemia.&nbsp;Here&rsquo;s a look back on the FDA happenings for the month of July 2018.

Atezolizumab (Tecentriq) has been granted a breakthrough therapy designation by the FDA for use in combination with&nbsp;bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma.