Cabozantinib Demonstrates OS, PFS Improvement in Advanced HCC
January 23rd 2018According to findings from the phase III CELESTIAL trial released ahead of the 2018 Gastrointestinal Cancers Symposium, cabozantinib (Cabometyx) improved median overall survival by 2.2 months compared with placebo for patients with previously treated advanced hepatocellular carcinoma.
Nab-Paclitaxel/Gemcitabine Induces Encouraging Responses in Locally Advanced Pancreatic Cancer
January 22nd 2018In patients with newly diagnosed locally advanced pancreatic cancer, induction treatment with nab-paclitaxel (Abraxane) plus gemcitabine induced an overall disease control rate of 77.6%, according to updated findings from the phase II LAPACT trial presented at the 2018 Gastrointestinal Cancers Symposium.
Frontline Daratumumab Granted FDA's Priority Review for Multiple Myeloma
January 22nd 2018Based on findings from the ALCYONE study, which were published in the <em>New England Journal of Medicine</em> and presented at the 2017 ASH Annual Meeting,<sup> </sup>the FDA has granted a priority review designation to daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Arsenic Trioxide Approved by FDA for Promyelocytic Leukemia
January 17th 2018Arsenic trioxide (Trisenox) has been approved by the FDA in combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.
Afatinib Approval for Lung Cancer Expanded by FDA
January 15th 2018The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include the treatment of patients with metastatic non–small cell lung cancer whose tumors harbor uncommon <em>EGFR</em> alterations in L861Q, G719X, and/or S768I.
Novel Iobenguane I-131 Agent Granted FDA's Priority Review for Rare Neuroendocrine Tumors
January 2nd 2018A 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.
Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based 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.
Stereotactic Radiotherapy Device Given Green Light for Early Breast Cancer by FDA
December 26th 2017Based 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 />
Novel Combination Shows Promising Responses in Pancreatic Cancer
December 19th 2017The 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 Demonstrates Responses in More Than 40% in Relapsed/Refractory IDH+ AML
December 16th 2017Ivosidenib (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.
Olaparib/Durvalumab Combo Demonstrates 80% DCR in HR+/HER2- Breast Cancer
December 16th 2017According 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.
Abemaciclib/Pembrolizumab Combo Shows Signs of Activity in HR+/HER2- Breast Cancer
December 16th 2017According 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.
Exciting Response Rates Seen in Updates Findings of bb2121 in Multiple Myeloma
December 13th 2017Chimeric 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 />
Liso-Cel Shows Potent, Durable Remissions in High-Risk DLBCL
December 12th 2017Updated 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.
High Response Rate Seen With Ibrutinib/Venetoclax in Relapsed/Refractory CLL
December 12th 2017In 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.
Benefits Maintained With Axi-Cel Long-Term for NHL
December 11th 2017Treatment 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 Improved With Nab-Paclitaxel in TNBC Subset
December 9th 2017Survival 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.
Continued Activity Reported for Pembrolizumab/Eribulin in TNBC
December 9th 2017Updated 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.
Disease Control Rate of 45% Achieved With Sacituzumab Govitecan in Heavily Pretreated TNBC
December 7th 2017An 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).
Early Study Results Show NKTR-214/Nivolumab Combination Active in Advanced Cancers
November 28th 2017For 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.
Entrectinib Demonstrates Durable Benefit for ROS1-Positive NSCLC
November 28th 2017According 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.
IMpower150 Trial Delays Progression in Advanced NSCLC With Atezolizumab/Bevacizumab Combo
November 21st 2017In 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.
Brentuximab Vedotin Submitted for FDA Approval as Treatment for Hodgkin Lymphoma
November 4th 2017Brentuximab 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.
Long-Term Benefit Maintained Across Subgroups of Melanoma With Dabrafenib/Trametinib Combo
October 22nd 2017Adjuvant 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).
Pilot Study of Engineered TILs Shows Early Responses in Advanced Melanoma
October 21st 2017In 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.
Immunotherapy/Targeted Therapy Combinations Show Promise in BRAF-Mutated Melanoma
October 21st 2017Triplet 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.