News

According to findings from the phase III ECHELON-2 trial presented at the 2018 ASH Annual Meeting, the use of brentuximab vedotin (Adcetris) in combination with chemotherapy demonstrated a clinically meaningful improvement in progression-free survival and overall survival in patients with CD30-expressing peripheral T-cell lymphoma. These data were also published online in&nbsp;<em>Lancet Oncology</em>.

A newly discovered recurrent mutation in the&nbsp;B-cell leukemia/lymphoma 2 protein&nbsp;in patients with chronic lymphocytic leukemia has been linked to venetoclax resistance.

Venetoclax monotherapy induced high rates of minimal residual disease in the peripheral blood and bone marrow in patients with&nbsp;relapsed/refractory chronic lymphoblastic leukemia in a pooled analysis of 2 clinical trials. Data from the analysis was reported during the poster session at the 2018 ASH Annual Meeting.

Based on findings from the phase III IMpower133 study, a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) has been granted a priority review by the FDA&nbsp;for use in combination with carboplatin and etoposide for the frontline treatment of&nbsp;patients with extensive-stage small cell lung cancer.

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

Two-year findings from the ZUMA-1 trial showed an overall survival rate of more than 50% from treatment with&nbsp;axicabtagene ciloleucel, a CD19-targeted CAR T-cell therapy&nbsp;in patients with&nbsp;refractory large B cell lymphoma; the median survival had not yet been reached. These data, representing a clear plateau in the survival curve, were presented at the 2018 ASH Annual Meeting.

During a&nbsp;<em>Targeted Oncology&nbsp;</em>case-based peer perspectives program, Benjamin P. Levy, MD, discussed his clinical considerations for the management of non&ndash;small cell lung cancer.

Lenalidomide in addition to rituximab, called the R² regimen, led to a significant increase in progression-free survival compared with rituximab alone in patients with&nbsp;relapsed/refractory indolent non-Hodgkin lymphoma in results from the phase III AUGMENT trial.

Overall survival was more than doubled when&nbsp;the CD79b-targeted antibody&ndash;drug conjugate polatuzumab vedotin was added to treatment with&nbsp;bendamustine and rituximab for patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma.

The gold standard of predicting how long patients with&nbsp;myelodysplastic syndromes could live with the disease may soon be replaced by a new approach. According to Aziz Nazha, MD, this newer approach utilizes machine learning to&nbsp;analyze genomic and clinical data from patients to more accurately predict survival.

Mosunetuzumab, a&nbsp;CD3 and CD20 bispecific antibody, induced complete remission rates over 30% in patients with&nbsp;relapsed/refractory follicular lymphoma and&nbsp;relapsed/refractory diffuse large B-cell lymphoma or transformed follicular lymphoma, and demonstrated a tolerable safety profile, showing promise for these patients with&nbsp;B-cell indolent and aggressive non-Hodgkin lymphomas.&nbsp;

According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment&nbsp;with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity in younger patients with low-risk diffuse large B-cell lymphoma. The progression-free survival rates were also similar between the 2 arms.&nbsp;

Two variants of the chemotherapy regimen R-CHOP resulted in comparable overall survival and progression-free survival in patients with previously untreated stage III or IV indolent B-cell lymphoma, including grades 1 to 3 follicular lymphoma, according to a long-term follow-up analysis from a combined phase II/III randomized trial.

The immunomodulating agent lenalidomide induced a complete response in 74% of patients with high tumor burden follicular lymphoma when used in combination with rituximab and a 4-drug chemotherapy regimen, according to a recent study.

Srdan Verstovsek, MD, PhD,&nbsp;discusses the second-line use of ruxolitinib in patients with in PV and additional benefits with the agent as more data become available.

During a&nbsp;<em>Targeted Oncology</em>case-based peer perspectives program, John Marshall, MD, reviewed his clinical considerations for the management of pancreatic cancer. Marshall discussed his treatment options and other factors that go into his decision making with the group during the meeting based on 2 case scenarios of patients with pancreatic adenocarcinoma.

Beginning ruxolitinib (Jakafi) therapy at lower doses may limit the anemia frequently seen early in treatment in patients with myelofibrosis while still providing clinical benefits like improvements in splenomegaly, according to the results of a 24-week open-label phase II dose escalation study.

In an interview with&nbsp;<em>Targeted Oncology</em>, Jonathon B. Cohen, MD, discussed the evolving treatment landscape of MCL.

Gilteritinib has been approved by the FDA&nbsp;for the treatment of adult patients with&nbsp;<em>FLT3</em>&nbsp;mutation&ndash;positive relapsed or refractory acute myeloid leukemia.

During a&nbsp;<em>Targeted Oncology&nbsp;</em>case-based peer perspectives program, Sikander Ailawadhi, MD, reviewed with other physicians his clinical considerations for the management of multiple myeloma. Ailawadhi discussed his treatment options and other factors that go into his decision making with the group during the meeting based on a case scenario of a patient with high-risk, transplant-ineligible multiple myeloma.

The FDA has granted approval to the&nbsp;rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy, making it the first&nbsp;biosimilar approved by the FDA for the treatment of patients with NHL.

In an interview with <em>Targeted Oncology</em>, Charalambos Andreadis, MD, MSCE, discussed the use of CAR T-cell therapy in patients with DLBCL, as well as the toxicities associated with each product. He also highlights other promising therapies in the treatment landscape.

A phase II trial is currently recruiting patients with Merkel cell carcinoma to participate in a single-arm study evaluating the safety and efficacy of INCMGA00012.¹The open-label, multicenter study seeks to enroll 90 patients, including at least 52 patients who are treatment-na&iuml;ve. In addition, only 40 patients who are chemotherapy-refractory will be allowed to participate

Toni K. Choueiri, MD, discusses pivotal phase III findings for the combination of axitinib plus&nbsp;avelumab in previously untreated patients with metastatic renal cell carcinoma.

The CheckMate-451 trial missed its primary endpoint of overall survival with the combination of&nbsp;nivolumab and ipilimumab as a maintenance therapy for patients with&nbsp;extensive-stage small cell lung cancer without disease progression following frontline platinum-based chemotherapy.

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.

Targeted agents have produced new treatment options for patients with advanced thyroid cancers, with significant advances being seen this year in moving toward precision medicine for various thyroid cancer subtypes, according to Marcia S. Brose, MD, PhD.&nbsp;

Patients with thyroid cancer classified as having low risk of disease recurrence can be treated safely with a lower dose of radiation following surgery, compared with the standard higher dose, according to long-term findings from the HiLo trial presented at the National Cancer Research Institute (NCRI) Cancer Conference.

A new drug application for&nbsp;quizartinib has been granted a priority review by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia. The designation is based on findings from the&nbsp;phase III QuANTUM-R study.&nbsp;

More research is still needed to determine the risk of developing a subsequent malignant neoplasm following radioactive iodine treatment for thyroid cancer, according to findings that were presented during the Annual Meeting of the American Thyroid Association and published in <em>Thyroid</em>.