News

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.

Marcia S. Brose, MD, PhD,&nbsp;discussed the clinical benefit of larotrectinib in treating patients with&nbsp;<em>TRK</em> fusion&ndash;positive papillary thyroid cancer.

The treatment regimen of&nbsp;nivolumab (Opdivo) at 1 mg/kg plus ipilimumab at (Yervoy) 3 mg/kg induced higher overall response rates and longer progression-free survival in patients with&nbsp;platinum-pretreated metastatic urothelial carcinoma, according to extended follow-up data reported at the 2018 ESMO Annual Congress.<br /> &nbsp;

Data from a posthoc analysis of the phase II QUADRA trial support the use of niraparib in later lines of therapy in patients with relapsed ovarian cancer who have&nbsp;<em>BRCA</em> mutations, said Kathleen N. Moore, lead investigator of the trial. According to findings reported at the 2018 ESMO Annual Congress, when used in the fourth line or later, niraparib exhibited an overall response rate of approximately 30% in this subset of patients.

The treatment landscapes of Hodgkin lymphoma and mantle cell lymphoma have progressed to a more personalized therapeutic approach in clinical practice due to the introduction of the latest novel regimens, according to&nbsp;Chaitra S. Ujjani, MD.

As an add-on to bevacizumab, carboplatin plus pegylated liposomal doxorubicin significantly extended progression-free survival compared with carboplatin and gemcitabine in patients with recurrent ovarian cancer whose first disease recurrence was &gt;6 months after first-line platinum-based chemotherapy.

According to a presentation at the 2018 ESMO Congress, risk of death was reduced with trifluridine/tipiracil versus placebo in patients with&nbsp;heavily pretreated gastric or gastroesophageal junction cancer.&nbsp;Lead TAGS trial author Hendrik-Tobias Arkenau, MD, PhD, said there was also improvement in progression-free survival and disease control.

Three months have been added on by the FDA to the review period for the supplemental biologics license application for the frontline treatment combination of nivolumab plus low-dose ipilimumab for patients with advanced non&ndash;small cell lung cancer with tumor mutational burden &ge;10 mutations per megabase.

In long-term follow-up results from the&nbsp;COMBI-AD trial, the relapse-free survival benefit with&nbsp;adjuvant dabrafenib (Tafinlar) and trametinib (Mekinist) was confirmed in&nbsp;patients with resected stage III <em>BRAF</em>-mutant melanoma. The follow-up data were reported by Georgina Long, MBBS, PhD, during the 2018 ESMO Congress in Munich, Germany.

Vivian G. Oehler, MD, discusses the diagnosis, risk prognostication, and therapeutic strategies for&nbsp;myeloproliferative neoplasms.

Michael Wang, MD,&nbsp;discusses the latest options for patients with relapsed MCL, while also addressing some of the challenges with these agents.

Patients with advanced or metastatic renal cell carcinoma who were treated with the combination of&nbsp;pembrolizumab (Keytruda) and&nbsp;axitinib (Inlyta) demonstrated a significantly improved survival benefit compared with&nbsp;sunitinib (Sutent)&nbsp;in the first-line setting, meeting the endpoints of the pivotal phase III KEYNOTE-426 trial.

Hassane M. Zarour, MD,&nbsp;discussed the research surrounding manipulation of the gut microbiome to improve response to immunotherapy in melanoma and other tumor types.

A&nbsp;supplemental new drug application for ibrutinib (Imbruvica) has been granted a priority review by the FDA&nbsp;for use in combination with obinutuzumab (Gazyva) as a frontline treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Genomic assays and signatures are increasingly being used as a prognostic indicator for guiding treatment decisions, according to Harold J. Burstein, MD, PhD. During a presentation at the 2018 Lynn Sage Breast Cancer Symposium in Chicago, he explained that many of these tests can also be used as predictive indicators.

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.

Talazoparib has been approved by the FDA for treatment of patients with deleterious or suspected deleterious germline <em>BRCA</em>-mutated, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the PARP inhibitor.

Although, it is challenging to determine the optimal&nbsp;adjuvant therapy for&nbsp;younger patients with breast cancer, Mark Robson, MD, encouraged that the addition of adjuvant chemotherapy does show a benefit in this patient population.&nbsp;

The role of&nbsp;tumor-infiltrating lymphocytes (TILs) is expanding in cancer care, necessitating a more involved role for pathologists to quantify immune infiltrates,&nbsp;K.P. Siziopikou, MD, PhD, suggested during a presentation at&nbsp;the 2018 Lynn Sage Breast Cancer Symposium.

According to topline findings, the phase III CheckMate-331 trial of nivolumab monotherapy for patients with small cell lung cancer who relapsed following platinum-based chemotherapy failed to meet its primary endpoint of improved overall survival compared with the standard topotecan or amrubicin.

Patients with HER2-positive, microsatellite instability-high (MSI-H), and <em>NTRK</em> gene fusion-positive breast cancer likely benefit more than others from molecular profiling. In a presentation at the 2018 Lynn Sage Breast Cancer Symposium in Chicago, Illinois,&nbsp;Sledge discussed the growing use of molecular profiling, especially for metastatic cancers, as well said the decreasing cost of sequencing.

LOXO-292 has been granted a breakthrough therapy designation by the FDA&nbsp;for treatment of patients with advanced RET fusion&ndash;positive thyroid cancer requiring systemic therapy, who have progressed on prior treatment and have no other acceptable alternative treatment options. Loxo Oncology, the developer of the selective RET inhibitor, released the news of the designation in a statement today.

An independent assessment conducted as part of the pivotal, international phase III REFLECT trial confirmed positive responses demonstrated by&nbsp;lenvatinib (Lenvima)&nbsp;as a first-line therapy for patients with HCC.

Axel Grothey, MD, recently shared the treatment considerations and decisions he makes when treating patients with colon cancer. Grothey, a medical oncologist at the West Cancer Center, explained how he would treat these patients based on case scenarios during a <em>Targeted Oncology</em> live case-based peer perspectives presentation.

Following recent FDA clearances, using scalp cooling to&nbsp;limit alopecia in patients receiving chemotherapy is closer to becoming a more common practice,&nbsp;according to a presentation at the 2018 Lynn Sage Breast Cancer Symposium.

David G. Maloney, MD, PhD,&nbsp;reviews the latest developments with CAR T-cell therapy in patients with non-Hodgkin lymphoma.

Lloyd Damon, MD,&nbsp;discussed novel therapies in AML with a focus on FLT3 and IDH1/2 inhibitors.<br /> &nbsp;

In a 16-0 vote, the&nbsp;FDA&rsquo;s Oncologic Drugs Advisory Committee has recommended the approval of&nbsp;the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody&rsquo;s non-Hodgkin lymphoma indications.

Shagun Arora, MD, discusses new agents and combination studies beyond chemoimmunotherapy for patients with CLL.

Guidelines from the International Lymphoma Radiation Oncology Group recommend the use of proton therapy in adults with mediastinal lymphomas and for young women. Specifically, clinicians should consider proton therapy in mediastinal disease that spans below the left main stem coronary artery and is near the front of, behind, or on the left side of the heart.