GIST

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

Olaparib (Lynparza) has been granted an orphan drug designation by the FDA for the treatment of patients with pancreatic cancer, 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, 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 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 as a first-line treatment for patients with unresectable hepatocellular carcinoma, based on data from the phase III REFLECT trial.

John L. Marshall, MD, chief of the  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’s needs before making a treatment decision. 

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.

The PD-1 inhibitor pembrolizumab (Keytruda) has been granted a priority review designation by the FDA for use in previously treated patients with advanced hepatocellular carcinoma,&nbsp;according to Merck, the manufacturer of the agent.

Consistent benefits and safety were seen with TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf) in a real-world treatment setting for patients with&nbsp;refractory metastatic colorectal cancer, according to preliminary data from the phase IIIb open-label PRECONNECT trial.&nbsp;

A strategy of escalating regorafenib from 80 mg to 160 mg per day was superior to starting at a dose of 160 mg per day in patients with refractory metastatic colorectal cancer, according to results from the regorafenib dose optimization study presented at the 2018 World Congress on GI.

According to findings from the&nbsp;IMblaze370 study, atezolizumab alone or in combination with cobimetinib did not demonstrate superior overall survival when compared with regorafenib for the treatment of&nbsp;patients with chemorefractory metastatic colorectal cancer. Findings from the study were presented at the 2018 World Congress on Gastrointestinal Cancer.

According to findings from the&nbsp;phase III KEYNOTE-061 study, second-line treatment with pembrolizumab (Keytruda) did not significantly improve overall survival or progression-free survival compared with&nbsp;paclitaxel&nbsp;in patients with advanced or metastatic gastric or gastroesophageal junction cancer with a PD-L1 combined positive score &ge;1.

In findings from the phase III TAGS study reported at the 2018 World&nbsp;Gastrointestinal Cancer Congress, TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf) was found to be an effective treatment option for patients with heavily pretreated&nbsp;metastatic or advanced gastric cancer, providing a&nbsp;31% reduction in the risk of death compared with placebo.

Treatment with&nbsp;trifluridine/tipiracil combined with bevacizumab improved&nbsp;progression-free survival over capecitabine plus bevacizumab in patients with&nbsp;metastatic colorectal cancer who are not eligible for chemotherapy or surgical resection,&nbsp;according to findings presented at the 20th World Conference of Gastrointestinal Cancer.&nbsp;<br /> &nbsp;

Bert H. O&rsquo;Neil, MD, recently shared his considerations for treatment when treating patients with gastrointestinal cancers. O&rsquo;Neil reviewed how he would treat patients with colon cancer and patients with hepatocellular carcinoma based on case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives presentation.<br /> &nbsp;