FDA Allows Trial Enrollment to Resume for Single-Agent Emavusertib in AML/MDS
August 30th 2022The FDA has granted permission for enrollment to resume in the monotherapy phase 1a portion of the phase 1/2 TakeAim Leukemia trial evaluating emavusertib in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.
Abivertinib Demonstrates Response and Survival Benefits in Pretreated EGFR T790M–Mutant NSCLC
August 23rd 2022The novel third-generation EGFR inhibitor abivertinib generated a positive overall response rate and overall survival in heavily pretreated Chinese patients with EGFR T790M–mutated non–small cell lung cancer who failed treatment on a first-line EGFR TKI, according to long-term follow-up data from a phase 1/2 trial (NCT02330367).
Maintenance With Niraparib and Ipilimumab Demonstrates PFS Benefit in Pancreatic Cancer
August 23rd 2022Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer who achieved a stable response to platinum-based chemotherapy.
FDA Grants Breakthrough Therapy Designation to Taletrectinib for ROS1+ NSCLC
August 23rd 2022The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.
FDA Grants Orphan Drug Designation to Fixed-Dose Senaparib/Temozolomide Combo for SCLC
August 19th 2022The FDA has granted an orphan drug designation to the fixed-dose combination capsule of the PARP inhibitor senaparib and temozolomide for the treatment of adult patients with small cell lung cancer.
Ruxolitinib/Pomalidomide Combo Shows Feasibility in Myelofibrosis With Anemia
August 16th 2022A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.
Nivolumab/Ipilimumab Combo Provides Long-Term Survival Benefit in Advanced HCC After Sorafenib
August 13th 2022The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.
Amivantamab/Lazertinib/Chemo Combo Achieves 50% ORR in Pretreated EGFR-Mutant NSCLC
August 8th 2022Amivantamab in combination with lazertinib plus carboplatin and pemetrexed elicited encouraging responses in pretreated patients with EGFR-mutant non–small cell lung cancer, according to findings from the phase 1 CHRYSALIS-2 trial.
Sotorasib Plus SHP2 Inhibition Elicits Promising Preliminary Activity in KRAS G12C–Mutated NSCLC
August 7th 2022The combination of sotorasib and the small molecule SHP2 inhibitor RMC-4630 led to an investigator-assessed objective response rate of 27% and 50% in pretreated and KRAS G12C inhibitor–naïve patients with non–small cell lung cancer, respectively.
Sitravatinib/Tislelizumab Combo Induces Antitumor Activity in PD-L1+ Advanced NSCLC
August 7th 2022Sitravatinib in combination with tislelizumab demonstrated a confirmed investigator-assessed overall response rate of 30.4% in patients with PD-L1–positive, treatment-naïve, locally advanced or metastatic squamous non–small cell lung cancer.
GDC-6036 Monotherapy Elicits Promising Responses in KRAS G12C–Mutant NSCLC
August 7th 2022GDC-6036, a novel KRAS G12C inhibitor, produced encouraging antitumor activity with a manageable safety profile as a single agent in previously treated patients with KRAS G12C–mutated NSCLC, according to data from a phase 1a trial.
Larotrectinib Demonstrates Favorable Long-Term Responses in NTRK Fusion–Positive Lung Cancer
August 6th 2022Larotrectinib continued to elicit durable responses and a low toxicity profile in patients with NTRK fusion–positive lung cancer, according to long-term follow-up data from the phase 2 NAVIGATE trial and phase 1 LOXO-TRK-14001 trial.
Ociperlimab Plus Tislelizumab Demonstrates Antitumor Activity in PD-L1+ NSCLC
August 6th 2022Ociperlimab, an anti-TIGIT monoclonal antibody, plus the anti–PD-L1 monoclonal antibody tislelizumab induced promising efficacy in adults with treatment-naïve, metastatic, PD-L1–positive non–small cell lung cancer, according to data from the dose-expansion cohort of the AdvanTIG-105 trial.
Azacitidine/Quizartinib Combo Showcases Early Activity in MDS, MDS/MPN With FLT3 or CBL Mutations
August 5th 2022The combination of azacitidine and quizartinib produced preliminary responses in patients with myelodysplastic syndrome and myelodysplastic syndrome/myeloproliferative neoplasms whose tumors harbored FLT3 or CBL mutations, according to data from a phase 1/2 trial (NCT04493138).
REGN5678 Plus Cemiplimab Demonstrates Early Activity in mCRPC
August 3rd 2022The novel PSMAxCD38 costimulatory bispecific antibody REGN5678 has shown encouraging efficacy in combination with cemiplimab in patients with advanced metastatic castration-resistant prostate cancer, according to preliminary findings from an ongoing phase 1/2 trial (NCT03972657).
CAR T-cell Therapy CT103A Produces Durable Responses in Relapsed/Refractory Multiple Myeloma
August 3rd 2022The fully human BCMA-directed CAR T-cell therapy, CT103A, demonstrated deepening efficacy with an acceptable toxicity profile in patients with relapsed or refractory multiple myeloma, according to updated data from the phase 1/2 FUMANBA-1 trial.
FDA Grants Fast Track Designation to OP-1250 in ER+/HER2- Metastatic Breast Cancer
August 2nd 2022The FDA has granted a fast track designation to OP-1250 for the treatment of patients with ER-positive, HER2- metastatic breast cancer who have progressed following at least 1 line of endocrine therapy with at least 1 line administered in combination with a CDK4/6 inhibitor.