ASCO 2019 Updates
Updated: Mar 29
Updates from Chicago:
Novartis has presented the clinical trial data of Kisqali in combination with endocrine therapy for the treatment of pre- and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer.
About MONALEESA-7 trail: (Phase 3)
Kisqali in combination with endocrine therapy was compared with endocrine therapy alone
Efficacy endpoint(s): Overall survival at 42 months
Results: 70.2% in patients on combination therapy versus 46.0% in patients on endocrine therapy alone
Novartis presented the investigational product canakinumab results for patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutation
About EOMETRY mono-1 trial: (Phase 2)
Patients were treated with 400 mg orally twice daily dose of canakinumab
Efficacy endpoint(s): Overall response rate
Results: 68% in treatment-naive patients and 41% in treated patients
TAFINLAR + MEKINIST
Novartis has presented five year survival data of Tafinlar and Mekinist combination. The study included more than 500 patients with BRAF mutated metastatic melanoma.
About COMBI-d and COMBi-v trials
Endpoint: Progression free survival and overall survival
Results: Five year progression free survival was observed in 19%, overall survival of 49% and 71% in the respective trials.
Kite announced Yescarta data from ZUMA-1 study in patients suffering from relapsed or refractory large B-cell lymphoma.
About ZUMA-1 trial: (Phase 2)
Patients were treated with Yescarta (axicabtagene ciloleucel)
Efficacy endpoint(s): Objective response rate (ORR), overall survival in two age groups (< 65 years and >65 years)
Results: ORR is 92% in >65years group, 81% in <65 years group; OS was 54% in >65 years group and 49% in <65 years group
LYNPARZA FOR OVARIAN CANCER
AstraZeneca and Merck’s Lynparza is the first PARP showed efficacy compared to chemotherapy in patients suffering from BRCA-mutated advanced ovarian cancer.
About SOLO-3 trial (Phase 3):
Patients with BRCA 1/2 mutated (gBRCAm) advanced ovarian cancer, received two or more prior therapies.
Endpoint: Objective response rate
Results: 72.2% in patients on Lynparza versus 51.4% in patients on chemotherapy
LYNPARZA FOR PANCREATIC CANCER
Lynparza has shown efficacy versus placebo in patients suffering from gremlin BRCA-mutated advanced adenocarcinoma of the pancreas.
About POLO trial (Phase 3):
gBRCA metastatic pancreatic cancer patients. Patients did not progress after indicating chemotherapy.
Endpoint: Progression free survival
Results: 7.4 months in patients on Lynparza versus 3.8 months in patients on placebo.
KEYTRUDA FOR NSCLC
Merck has presented the long term survival data of Keytruda in patients suffering from advanced non-small cell lung cancer.
About KEYNOTE trial:
KEYNOTE-001 is a Phase 1b trial involving 550 patients who were treatment naive and experienced patients.
Endpoints: Overall survival (primary), progression-free survival, overall survival and duration of response.
Results: Overall survival was 23.2% in treatment-naive patients and 15.5% in treatment-experienced patients.
KEYNOTE-189 was a Phase 3 trial comparing Keytruda + Alimta (pemetrexed) + chemotherapy vs. Pemetrexed + chemotherapy.
Endpoint: Overall survival
Results: 44.4% reduction in risk of death compared to the patients who were treated with chemotherapy alone.
Janssen presented the clinical trial data of Imbruvica in patients suffering from chronic lymphoblastic leukaemia (CLL) demonstrating the safety and sustained efficacy.
About RESONATE-2 study (five year follow-up study)
Patients are treated with Imbruvica and ofatumumab
Efficacy endpoint: Progression-free survival at 65.3 months
Results: 67.7 months in patients on Imbruvica versus 65.1 months in patients on the ofatumumab
AbbVie is presenting more than 40 clinical trail outcomes of its anticancer products for more than fifteen different cancers.
Trail data of venetoclax + obinutuzumab vs. obinutuzumab + chlorambucil: Treatment is intended for chemotherapy-free therapy for patients with chronic lymphocytic leukemia who are not treated with any other medicines before. The product got recent approval from the US FDA.
Amgen has presented the data of first KRASG12C inhibitor AMG 510 for patients suffering from solid tumors.
14 patients included with 14 non-small cell lung cancer and 19 colorectal cancer and two other
Results: 13 of 18 patients with colorectal cancer had stable disease. Among the patients suffering from non-small cell lung cancer, five out of ten patients had a partial response; four had stable disease
Iberdomide with dexamethasone
Celgene has presented the data of Iberdomide for treatment of relapsed and refractory multiple myeloma. The study is a Phase 1/2 trial.
Endpoints: Safety and efficacy
Results: Overall response was 32%, partial response was achieved in 29%. Six patients were discontinued because of the severe adverse events.
Celgene has presented Phase 2 Jakarta2 study showing the significant response rate of Fedratinib in patients suffering with myelofibrosis; who were treated with ruxolitinib before the treatment.
Study details of JAKARTA2:
Endpoint: Spleen volume response rate
Results: 31% patients showed reduction after 6 months of treatment
Tecentriq (atezolizumab), Avastin (bevacizumab), carboplatin and paclitaxel
Roche presented the data of Tecentriq (atezolizumab), Avastin (bevacizumab), carboplatin and paclitaxel versus Avastin plus chemotherapy.
About Phase III IMpower150 study
Indicated in patients who are chemotherapy-naïve for metastatic non-squamous non-small cell lung cancer
Endpoint: Overall survival
Results: 13.3 in Tecentriq (atezolizumab), Avastin (bevacizumab), carboplatin and paclitaxel versus 9.4 months in patients on Avastin plus chemotherapy
Astellas has presented the data of the enfortumab vedotin in patients suffering from advanced urothelial cancer. The drug is indicated for patients who had previously treated with chemotherapy and a PD-1 or PD-L1 inhibitor.
About EV-201 (Phase 2)
End point: Overall response rate and complete response
Results: 44% of overall response rate and 12% complete response was observed in patients treated with enfortumab vedotin