A new drug application for the novel version of the radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent pheochromocytoma or paraganglioma, according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.
Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br />
Bosutinib (Bosulif) has been approved by the FDA as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
The combination of the novel tumor-associated macrophage (TAM)-targeting agent cabiralizumab and the PD-1 inhibitor nivolumab (Opdivo) resulted in intriguing objective response rates in heavily pretreated patients with metastatic pancreatic cancer, according to findings from a phase I study presented at the 2017 SITC Annual Meeting.
Ivosidenib (AG-120), an IDH1 inhibitor, demonstrated an objective response rate (ORR) of 41.6% in patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia (AML), according to findings from a single-arm phase I study.
According to phase II findings from the MEDIOLA trial presented at the 2017 San Antonio Breast Cancer Symposium, the combination of olaparib and durvalumab demonstrated a disease control rate of 80% for pretreated patients with germline <em>BRCA-</em>mutated, HER2-negative metastatic breast cancer, according to phase II findings from the MEDIOLA trial.
According to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium, the combination of abemaciclib and pembrolizumab showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer.
Daratumumab (Darzalex) in combination with VMP (bortezomib [Velcade], melphalan, and prednisone) could become a new standard of care for patients with newly diagnosed multiple myeloma who are unable to undergo transplant following findings from the phase III ALCYONE study.
Chimeric antigen receptor T-cell therapy with bb2121 demonstrated an objective response rate of 94% in patients with relapsed/refractory multiple myeloma, according to findings from a dose-escalation study. The senior study author, James N. Kochenderfer, MD, presented updated findings from the study during the 2017 ASH Annual Meeting, and commented that 89% of patients had a very good partial response or better, and 56% of patients had a complete remission. <br />
Updated results from the TRANSCEND study demonstrated that liso-cel (lisocabtagene maraleucel), formally known as JCAR017, induced an 81% objective response rate and a 63% complete remission rate in patients with relapsed/refractory diffuse large B-cell lymphoma.
In patients with relapsed/refractory chronic lymphocytic leukemia (CLL), ibrutinib (Imbruvica) in combination with venetoclax (Venclexta) induced an objective response rate (ORR) of 100%, according to findings from the TAP CLARITY clinical trial.
Treatment with the chimeric antigen receptor T-cell therapy axi-cel (axicabtagene ciloleucel; Yescarta) demonstrated improvement in long-term survival rates in patients with refractor, aggressive non-Hodgkin lymphoma, according to updated findings from the pivotal ZUMA-1 trial.
Survival rates improved with nab-paclitaxel (Abraxane) therapy compared with paclitaxel in patients with triple-negative breast cancer (TNBC) more than in other patient subsets, according to findings from a post-hoc analysis from the CALGB 40502/NCCTG N063H clinical trial.
Updated results of the phase Ib/II ENHANCE1/KEYNOTE-150 study presented at the 2017 San Antonio Breast Cancer Symposium found that the combination of pembrolizumab (Keytruda) and eribulin (Halaven) was associated with a 26.4% objective response rate for patients with metastatic triple-negative breast cancer.
An overall disease control rate of 45% was achieved with sacituzumab govitecan (IMMU-132) therapy in patients with heavily pretreated metastatic triple-negative breast cancer (mTNBC), according to updated findings of a study presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).
For patients with advanced cancers, including melanoma, non–small cell lung cancer, and renal cell carcinoma, the combination of the CD122-biased cytokine NKTR-214 and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72%, according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.
According to findings presented at the 2017 World Conference on Lung Cancer, the potent and selective inhibitor of ROS1 and TRKentrectinib induced an objective response rate of 68.8% by blinded independent central review, which included 2 complete responses (6.3%), for patients with <em>ROS1</em> fusion-positive advanced non–small cell lung cancer.
In topline results announced from the phase III IMpower150 trial, atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) and chemotherapy delayed progression or death when compared with bevacizumab and chemotherapy alone for patients with advanced nonsquamous non–small cell lung cancer.
Vemurafenib (Zelboraf) has been granted approval by the FDA as a treatment for patients with <em>BRAF</em> V600-mutated Erdheim-Chester disease (ECD). This is the first approved therapy for this rare blood disorder.
Brentuximab vedotin (Adcetris) has been submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics, the company developing brentuximab vedotin, recently announced the submission of a supplemental new drug application for the CD30-targeted antibody-drug conjugate.
Acalabrutinib (Calquence) received an accelerated approval from the FDA for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior regimen.
Adjuvant treatment with a combination of dabrafenib (Tafinlar) and trametinib (Mekinist) continues to show a long-term survival benefit in patients with melanoma, even across subgroup populations, according to a presentation at the 2017 World Congress of Melanoma (WCM).
In a small phase I study, engineered tumor-infiltrating lymphocytes demonstrated signs of antitumor activity in patients with metastatic melanoma following treatment with a prior checkpoint inhibitor. Results of the pilot study of TILs that were engineered to express transforming growth factor-β dominant negative receptor and nerve growth factor receptor were presented during the 2017 World Congress of Melanoma.
Triplet therapy with the combination of anti–PD-1/PD-L1 therapy, BRAF, and MEK inhibitors have already shown promise for patients with <em>BRAF</em>-positive advanced melanoma, and the potential for these combinations are increasing, according to Antoni Ribas, MD, PhD.
The CD19-directed CAR T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.
A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai, the company developing the therapy.
Frontline treatment with the combination of dabrafenib and trametinib induced an objective response rate of 64% (95% CI, 46%-79%) and a disease control rate of 75% in patients with <em>BRAF</em>-mutant metastatic non–small cell lung cancer.
After a median follow-up of 2.8 years, the 3-year relapse-free survival rate in patients with <em>BRAF</em>-mutant stage III melanoma who were treated with adjuvant dabrafenib and trametinib was 58% compared with 39% for placebo, according to findings from the phase III COMBI-AD study.
When abemaciclib was added to a non-steroidal aromatase inhibitor in treatment-naive patients with HER2-negative, HR-positive advanced breast cancer, the combination reduced the risk of progression of disease or death by 46% compared with either anastrozole or letrozole alone, according to findings from the phase III MONARCH 3 trial.