A subcutaneous formulation of daratumumab showed similar efficacy to the original intravenous formulation of daratumumab in the phase III COLUMBA trial of patients with relapsed/refractory multiple myeloma. The subcutaenous flat-dose of daratumumab also showed a reduction in the treatment burden, according to results presented at the 2019 ASCO Annual Meeting.
Updated data from the phase III EORTC 18071 study showed that patients with surgically resected high-risk, stage III melanoma experienced a 25% reduction in the risk of recurrence or death with adjuvant ipilimumab compared with placebo.
According to findings from the phase III MONALEESA-7 trial, peri and premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer treated with ribociclib plus endocrine therapy demonstrated an estimated overall survival rate of 70.2% at 42 months compared with 46% for placebo and endocrine therapy.
Each of the many BCMA-targeted CAR T cells in development demonstrate a different efficacy and safety profile, and each have different constructs. None of the agents have reached the FDA yet, but data for many of the agents were presented at the 2018 ASH Annual Meeting.
Two-year findings from the ZUMA-1 trial showed an overall survival rate of more than 50% from treatment with axicabtagene ciloleucel, a CD19-targeted CAR T-cell therapy in patients with 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.
Initial results from a phase I study showed an objective response rate of 83.3% had been achieved in heavily pretreated patients with relapsed/refractory multiple myeloma who had been treated with the anti-BCMA CAR T-cell therapy bb21217.
Mosunetuzumab, a CD3 and CD20 bispecific antibody, induced complete remission rates over 30% in patients with relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma or transformed follicular lymphoma, and demonstrated a tolerable safety profile, showing promise for these patients with B-cell indolent and aggressive non-Hodgkin lymphomas.
After 7 years of follow-up, single-agent ibrutinib demonstrated continued efficacy in the frontline and heavily pretreated, relapsed/refractory settings for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
After a median of 19 months of follow-up, durable objective response rates were sustained with tisagenlecleucel in patients with relapsed or refractory diffuse large B-cell lymphoma. These updated findings from the phase II JULIET study were presented at the 2018 ASH Annual Meeting.
According to updated data from the phase II ELIANA study, CD19-targeted CAR T-cell therapy tisagenlecleucel as treatment of pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia sustained rates of relapse-free survival and overall survival at 24 and 18 months.
Personalized immunotherapy regimens for patients with cancer is a long-term goal of the immuno-oncology field, yet progress toward this goal necessitates the discovery of an effective biomarker for guiding treatment decision making, according to Jason Luke, MD.
The high durable response rates seen with CAR T-cell therapies have helped fill a high unmet need for patients with relapsed/refractory diffuse large B-cell lymphoma, with questions remaining on the optimal way to use these agents following the FDA approval of 2 therapies in the past year, explained Anas Younes, MD, during a presentation at the <em>36th Annual </em>CFS.
Quick progress was seen with a novel class of agents, chimeric antigen receptor T-cell therapies, in the setting of diffuse large B-cell lymphoma—a swift jump from early phase clinical trials to FDA-approved products.
Moxetumomab pasudotox has been approved by the FDA for the treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.
The review period for a supplemental biologics license application seeking the approval of atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin), carboplatin, and paclitaxel or the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer has been extended by the FDA.
LOXO-292 has been granted a breakthrough therapy designation by the FDA for the treatment of patients with <em>RET</em> fusion–positive non–small cell lung cancer or <em>RET</em>-mutant medullary thyroid cancer.
RET will join the ever-expanding actionable driver mutations for non–small cell lung cancer, according to a presentation by Paul Baas, MD, PhD, at the <em>19th Annual</em> International Lung Cancer Congress.
Combinations with immunotherapy agents have surged ahead with new regimens showing great potential for the treatment of patients with lung cancer, Corey Langer, MD, said during a presentation at the <em>19th Annual </em>International Lung Cancer Congress (ILCC). Knowledge about a growing number of biomarkers are helping to guide treatment decisions with these combination options, he said, but the one standard of care has not yet been determined.
Several novel agents are beginning to show promise for new targets in non–small cell lung cancer, especially <em>NRG1</em> and <em>LKB1, </em>and could be positioned to join already established standard-of-care therapies.
Several studies presented at the 2018 ASCO Annual Meeting helped further refine and inform treatment strategies for the budding class of CAR T-cell therapies, particularly those directed at CD19, in patients with hematologic malignancies, with a focus on predicting adverse events and optimizing efficacy.
Now that chimeric antigen receptor T-cell therapies have received FDA approval for diffuse large B-cell lymphoma (DLBCL) after moving quickly through early phase clinical trials, research is now exploring ways to shift these agents earlier in the treatment paradigm, according to a discussion at the 2nd Annual Live Medical Crossfire on Hematologic Malignancies.
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 IMblaze370 study, atezolizumab alone or in combination with cobimetinib did not demonstrate superior overall survival when compared with regorafenib for the treatment of patients with chemorefractory metastatic colorectal cancer. Findings from the study were presented at the 2018 World Congress on Gastrointestinal Cancer.
According to phase I findings recently published in the<em> New England Journal of Medicine, </em><sup> </sup>the recombinant oncolytic poliovirus PVSRIPO demonstrated a 2- and 3-year overall survival (OS) rate of 21% (95% CI, 11%-33%) for patients with recurrent grade IV malignant glioblastoma.
Overall survival was not improved with the combination of palbociclib and fulvestrant compared with fulvestrant and placebo in the phase III PALOMA-3 trial for patients with HR-positive, HER2-negative metastatic breast cancer who received prior endocrine therapy, according to Pfizer, the developer of the CDK4/6 inhibitor.
The FDA has added PD-L1 status to the labels for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma. The addition was made based on lower overall survival rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.
Osimertinib (Tagrisso) has been approved by The European Commission as a frontline treatment for patients with <em>EGFR</em>-mutant locally-advanced or metastatic non–small cell lung cancer. The approval is based on data from the phase III FLAURA trial.
Overall survival improved with the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel versus a treatment regimen of bevacizumab and chemotherapy alone in patients with advanced wild-type nonsquamous non–small cell lung cancer.
Durable complete remissions were seen in 46% of patients with high-risk diffuse large B-cell lymphoma treated with the CAR T-cell therapy lisocabtagene maraleucel at 6 months. These results come from the updated findings from the phase I, multicenter TRANSCEND trial that were presented at the 2018 ASCO Annual Meeting.
Based on data reported at the 2018 ASCO Annual Meeting, the primary endpoint of the phase III RELEVANCE trial was not met with the combination of rituximab plus lenalidomide showing similar efficacy results compared with rituximab plus chemotherapy in treatment-naive patients with follicular lymphoma. The chemotherapy-free regimen, however, did show a more favorable toxicity profile.