Silas Inman

A collection of early phase clinical trials presented at the 2015 ASCO Annual Meeting demonstrated promising results for several novel agents in combination with established treatments for patients with hepatocellular carcinoma.

Second-line treatment with atezolizumab (MPDL3280A) has met the primary endpoint of a pivotal phase II study by effectively shrinking tumors in patients with locally advanced or metastatic urothelial bladder cancer.

ODAC supported the approval of necitumumab in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer.

Adding an NK1 antagonist to a 5-HT3 receptor antagonist with dexamethasone improved antiemetic control for patients with colorectal cancer treated with an oxaliplatin-based regimen compared with the 5-HT3 antagonist and dexamethasone alone.

Rolling submission of a new drug application for rociletinib has been initiated for patients with EGFR T790M-positive metastatic non–small cell lung cancer following prior treatment with an EGFR-targeted therapy.

The FDA has extended the review period for the MEK inhibitor cobimetinib in combination with the BRAF inhibitor vemurafenib (Zelboraf) for patients with BRAFV600 mutation-positive advanced melanoma by 3 months, making the new decision date November 11, 2015.

Celgene has entered into a 10-year collaboration with the cellular immunotherapy company Juno Therapeutics, which includes an initial $1 billion payment.

The FDA has assigned a priority review designation to MM-398 in combination with 5-fluorouracil and leucovorin for patients with metastatic pancreatic cancer following treatment with a gemcitabine-based therapy.

Chemotherapy-free neoadjuvant treatment with trastuzumab emtansine demonstrated a pathological complete response rate of 40.5% in patients with HER2+ and HR+ early breast cancer.

The European Commission has approved nivolumab as a treatment for patients with advanced melanoma in the first- and later-line setting regardless of BRAF mutation status, making it the first PD-1 inhibitor to gain approval in Europe.

Second-line treatment with ramucirumab did not improve overall survival compared with placebo in the full population of patients with advanced hepatocellular carcinoma examined in the phase III REACH study.

Patients with chemorefractory KRAS wild-type metastatic colorectal cancer had a statistically significant improvement in overall survival when treated with panitumumab (Vectibix) versus best supportive care, according to data released from a phase IlI study.

The addition of PEGPH20 to standard nab-paclitaxel and gemcitabine improved progression-free survival by 4.9 months compared with the two agents alone in untreated patients with advanced pancreatic cancer who expressed high-levels of hyaluronan.

The IDH1 inhibitor AG-120 and the IDH2 inhibitor AG-221 have demonstrated promising outcomes in patients with hematologic malignancies, including those with acute myeloid leukemia in two separate phase I clinical trials.

Treatment with inotuzumab ozogamicin demonstrated a complete response (CR) or CR with incomplete platelet recovery rate of 80.7% in patients with relapsed or refractory acute lymphoblastic leukemia.

The addition of panobinostat to bortezomib and dexamethasone improved progression-free survival by 7.8 months in a subgroup of 147 patients with multiple myeloma who had received at least 2 prior treatments, including bortezomib and an immunomodulatory agent.

Adding ofatumumab to fludarabine and cyclophosphamide reduced the risk of disease progression by 54% in patients with relapsed chronic lymphocytic leukemia.

A retrospective analysis of the phase III GOG-0218 trial has identified a potential biomarker of response for bevacizumab in patients with advanced ovarian cancer.

Treatment with the PARP inhibitor rucaparib demonstrated robust clinical activity and a tolerable safety profile for women with biomarker-defined relapsed ovarian cancer

The combination of dabrafenib, trametinib, and panitumumab showed promising clinical activity in BRAFV600E-mutated metastatic colorectal cancer.

The combination of lenvatinib and everolimus more than doubled progression-free survival and extended overall survival by 10.1 months compared with everolimus alone as a second-line treatment for patients with metastatic renal cell carcinoma.

The CD19-targeted chimeric antigen receptor T-cell therapy CTL019 demonstrated early evidence of activity and safety in patients with refractory multiple myeloma.

The FDA has scheduled an ODAC advisory hearing to discuss the biologics license application for necitumumab in combination with gemcitabine and cisplatin as a first-line treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer.

Monoclonal antibodies against PD-1 and PD-L1 have demonstrated encouraging signs of antitumor activity for patients with pretreated advanced ovarian cancer.

Treatment with neratinib immediately following adjuvant trastuzumab plus chemotherapy modestly improved invasive disease-free survival against placebo at the cost of low-grade diarrhea in almost all patients with HER2-positive early-stage breast cancer.

Treatment with eribulin (Halaven) improved overall survival by 2 months compared with dacarbazine in patients with advanced leiomyosarcoma and adipocytic sarcoma.

Novel targeted therapies against ALK, BRAF, and RET have demonstrated promising outcomes in molecularly-defined patients with non-small cell lung cancer.

Treatment with atezolizumab doubled overall survival compared with docetaxel in previously treated patients with PD-L1-positive squamous and non-squamous non-small cell lung cancer.

Daratumumab demonstrated a 65% one-year overall survival rate and a 29.2% objective response rate in patients with double refractory heavily pretreated multiple myeloma.

Treatment with the PD-1 inhibitor pembrolizumab demonstrated high response rates in patients with heavily pretreated colorectal cancer who harbored genetic defects in mismatch repair.