NOVARTIS
Kymriah demonstrated a strong response in patients with relapsed or refractory follicular lymphoma
Novartis presented the primary analysis of the Phase II ELARA trial. Kymriah (tisagenlecleucel) demonstrated a 66% complete response rate and 86% overall response rate. However, the median duration of response, progression-free survival (PFS), and overall survival (OS) was not reached.
Patients have not experienced 3/4 cytokine release syndrome.
Kisqali reported most extended OS in HR+/HER2- breast cancer
Novartis presented the MONALEESA-3 trial demonstrating median overall survival (OS) of Kisqali in patients with postmenopausal HR+/HER2- metastatic breast cancer patients.
The median overall survival was 53.7 months in postmenopausal HR+/HER2-metastatic breast cancer patients.
The relative risk of death was reduced by 36% in the first-line (1L) postmenopausal population.
The time to chemotherapy was delayed by 48.1 months compared to the patients on fulvestrant only (28.8 months).
Tabrecta demonstrated an OS of 20.8 months in 1st line and 13.6 months in 2nd line METex14 NSCLC patients
Novartis presented the first published overall survival (OS) in patients with METex14 NSCLC patients.
The company has presented the Phase II GEOMETRY study. Tabrecta showed a median overall survival of 20.8 months in treatment naïve patients and 13.6 months in previously treated patients.
The overall response rate was 65.6% in first-line and 51.6% in second-line patients.
Novartis presented Phase III tislelizumab trial for esophageal cancer after systemic therapy
Novartis presented the Phase III RATIONALE 302 trial tislelizumab, demonstrating better overall survival than chemotherapy. The median OS was 8.6 months vs. 6.3 months in patients on chemotherapy. In addition, the median OS was increased by 2.3 months; the risk of death was reduced by 30%.
The median progression-free survival was 1.6 months in tislelizumab versus 2.1 months in patients on chemotherapy. The objective response rate was 20.3% versus 9.8%.
ROCHE
Tecentriq helps people with early lung cancer liver longer
Roche presented the pivotal Phase III data of Tecentriq, demonstrating the improved disease-free survival in patients with PD-L1-positive resectable early-stage lung cancer versus standard of care.
The company has presented a Phase III IMpower010 study; Tecentriq reduced the risk of disease recurrence or death by 34% compared to standard of care in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1≥1%.
After a median time of 32.2 months, in the larger population, the risk of disease recurrence or death decreased by 21%.
MERCK
Keytruda reduced the risk of disease recurrence or death by 32% in RCC patients after surgery
Merck announced the pivotal Phase 3 KEYNOTE-564 trial, the first Phase III trial of immunotherapy in patients with renal cell carcinoma (RCC).
Keytruda demonstrated the superiority over placebo in reducing the risk of recurrence or death by 32% versus placebo after a median follow-up of 24.1 months.
Lynparza reduced the risk of recurrence or death by 42% vs. placebo in germline BRCA+ high-risk HER2-negative early breast cancer
AstraZeneca and Merck announced Phase 3 OlympiA trial of Lynparza in patients with germline BRCA+ high-risk HER2-negative early breast cancer.
Lynparza demonstrated statistically significant improvement in primary endpoint - invasive disease-free survival; invasive breast cancer recurrences, second cancers, or death decreased by 42% vs. placebo.
85.9% of patients on Lynparza were alive and free of invasive breast cancer and second cancers compared to 77.1% in patients on placebo.
GILEAD
Kite presented results of ZUMA-3; Tecartus showed a high response rate in B-cell ALL patients
Kite presented the ZUMA-3 trial results, showing a high response rate in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
71 patients were administered with Tecartus (brexucabtagene autoleucel), 47% of patients were prior treated with three or more prior therapies. After a median follow-up of 16.4 months, 71% of patients showed a complete response.
60% of patients showed complete response in patients prior treated with blinatumomab.
Trodelvy showed superiority vs. SoC in triple-negative breast cancer patients
Gilead presented the Phase III ASCENT study, demonstrating the efficacy of Trodelvy (sacituzumab govitecan) in relapsed or refractory metastatic triple-negative breast cancer patients.
The median progression-free survival was 5.7 months versus 1.5 months in patients on chemotherapy. The median overall survival was 10.9 months versus 4.9 months in patients on chemotherapy. Further, the drug has shown an improved overall response rate (30%) than chemotherapy (3%).
ASTRAZENECA
AstraZeneca presented long-term Phase III data of Imfinzi in NSCLC patients
AstraZeneca presented PACIFIC Phase III trial of Imfinzi (durvalumab), showing sustained overall survival (OS) and progression-free survival (PFS).
Estimated overall survival was 43% versus 33.4% on placebo. The median overall survival was 47.5 months versus 29.1 months in patients on placebo. For patients who were treated for one year, 33.1% of patients have not progressed the disease versus 19% in patients on the placebo arm.
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