News

According to results from an extended follow-up of the CheckMate-205 trial looking at patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation, nivolumab (Opdivo) caused an overall objective response rate of 69%.

According to results published in <em>The&nbsp;New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.

Moxetumomab pasudotox has been granted a priority review by the FDA for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune),&nbsp;the developer of the anti-CD22 recombinant immunotoxin.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto)&nbsp;for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here&rsquo;s a look back on the FDA happenings for the month of March 2018.

A&nbsp;marketing authorization application for olaparib (Lynparza) for the&nbsp;treatment of women with <em>BRCA</em>-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting has been accepted by the&nbsp;European Medicines Agency.

In an interview with <em>Targeted Oncology</em>, Kris, a medical oncologist and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center, discussed how the approval of durvalumab has changed the treatment landscape of NSCLC.

Based on data from the phase III 482 study, denosumab (Xgeva) has been approved for an expanded indication by the European Commission&nbsp;for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

Ani S. Balmanoukian, MD,&nbsp;discusses immunotherapy developments in GU malignancies

Stuart L. Goldberg, MD,&nbsp;discussed the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome.

The Association of Community Cancer Centers (ACCC) has named Thomas A. Gallo, MS, MDA, as the 2018-2019 president of ACCC. This was announced at the ACCC&rsquo;s 44th Annual Meeting &amp; Cancer Center Business Summit on March 16, 2018.

The European Society for Medical Oncology in conjunction with the International Association for the Study of Lung Cancer has selected Fabrice Barlesi, MD, PhD, to receive the 2018 Heine H. Hansen Award. Barlesi will be presented with the award at the 2018 European Lung Cancer Congress, which will be held April 11-14 in Geneva, Switzerland.

In an interview with <em>Targeted Oncology</em>, Pollack, assistant member, Clinical Research Division, assistant professor, Division of Oncology, University of Washington, and attending physician at Seattle Cancer Care Alliance, discussed some of the advancements his lab is making in the field of sarcoma.

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the&nbsp;treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

A marketing authorization for ABP 980, a biosimilar to trastuzumab (Herceptin), has been issued a positive opinion by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use (CHMP).

According to early results of an ongoing early-phase study presented at the 2018 Society of Interventional Radiology Annual Scientific Meeting, image-guided injections of talimogene laherparepvec immunotherapy (T-VEC, Imylgic) were deemed tolerable in patients with advanced-stage liver metastases.

The combination of first-line platinum-containing chemotherapy plus the anti-PD-1 agent pembrolizumab (Keytruda), followed by pembrolizumab maintenance therapy, was safe and tolerable in patients with&nbsp;advanced ovarian cancer, according to preliminary data from a small clinical trial presented at the 2018 Society of Gynecologic Oncology Annual Meeting.

Mixed results have occured in recent trials testing immuotherapy in patients with breast cancer. Checkpoint inhibitors have been used as monotherapy in a pair of trials, reporting lackluster overall response rates. When immunotherapy was paired with chemotherapy, on the other hand, it usually showed better results, and gave signals that immunotherapies combined with targeted agents could work better than immunotherapy alone.

There has been a supplemental biologics license application (sBLA) granted priority review by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cases of metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

The new drug application for larotrectinib (LOXO-101) for treatment of patients with locally advanced or metastatic solid tumors that harbor an NTRK gene fusion&nbsp;has been completed.&nbsp;

Bruce D. Cheson, MD, recently shared the treatment options and decisions he makes when treating patients with follicular lymphoma based on 2 case scenarios during a <em>Targeted Oncology</em> live case-based peer perspective presentation.

The treatment landscape of non-small cell lung cancer has been identifying the importance of immunotherapy already, but combination therapies will soon play a large role in treatment of these patients as well, according to Chad Pecot, MD.

Enfortumab vedotin has been granted a breakthrough therapy designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy. These findings have been released by Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate.

According to findings from the phase III IMpower150 trial,&nbsp;significant improvement was found in overall survival with a treatment regimen of atezolizumab, bevacizumab, carboplatin, and paclitaxel compared to the combination of bevacizumab and chemotherapy alone for patients with advanced nonsquamous non&ndash;small cell lung cancer.

According to findings from the phase III MURANO trial recently published in the<em> New England Journal of Medicine, </em>the venetoclax&nbsp;(Venclexta) plus rituximab&nbsp;(Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab&nbsp;(Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia<em>.</em>

Treatment of renal cell carcinoma (RCC) is awaiting the potential integration of combinations of immuno-oncology agents like nivolumab (Opdivo) and ipilimumab (Yervoy), or combinations of targeted therapies with checkpoint inhibitors into the treatment paradigm. In an interview with&nbsp;<em>Targeted Oncology</em>, Robert A. Figlin, MD, discusses the expanding RCC armamentarium and balancing the benefits and risks of standard and emerging treatments to achieve optimal outcomes.

Based on data from 2 clinical trials, nilotinib&nbsp;(Tasigna) has been approved by the FDA for the first- and second-line treatment of&nbsp;pediatric patients aged 1 year and older with Philadelphia chromosome&ndash;positive chronic myeloid leukemia in the chronic phase.&nbsp;

Internationally renowned expert, Johanna C. Bendell, MD, has been promoted to chief development officer at Sarah Cannon. Her title responsibilities include developing and expanding physician, site, and Pharma relationships across the Sarah Cannon Network, thereby expanding the organization&rsquo;s efforts to bring more qualitative treatment options to its patients.

The combinations of atezolizumab and cobimetinib induced a 31% disease control rate in patients with heavily-pretreated metastatic colorectal cancer.&nbsp;Results from a 2-stage phase Ib study presented at the 2018 Gastrointestinal Cancers Symposium demonstrated an overall response rate of 8% (n = 7). All responses were partial responses.&nbsp;

Kornelia Polyak, MD, PhD,&nbsp;discusses several exciting advancements in the field of breast cancer, including immunotherapy, PARP inhibitors, and liquid biopsies.

Patients with oligodendroglioma developed pseudoprogression earlier after treatment with proton therapy compared with after photon therapy, according to the results of a retrospective study comparing the rates of pseudoprogression that occurred in patients with anaplastic gliomas following treatment with different radiation therapy modalities.