NOVARTIS
Novartis presented one year of additional overall survival benefit of Kisqali in patients with advanced breast cancer.
Novartis presented exploratory analysis from MONALEESA-2, -3, and -7 studies, demonstrating the overall survival (OS) benefit of Kisqali plus endocrine therapy versus endocrine therapy alone in breast cancer patients with challenging visceral metastases.
Kisqali plus endocrine therapy showed nearly one year of survival benefit compared to endocrine therapy alone in harder to treat population.
In patients with visceral metastases—including liver metastases and multiple metastatic sites, the overall survival was 62.7 months in patients on Kisqali plus endocrine therapy compared to 52.1 months in patients on endocrine therapy alone.
Novartis has also presented the trial design of the HARMONIA trial, the first head-to-head trial of CDK4/6 inhibitors comparing Kisqali versus Ibrance (palbociclib) in patients with advanced HR+/HER2-, HER2-enriched subtype, breast cancer. Novartis is aiming to demonstrate a better response to Kisqali compared to Ibrance. Progression-free survival was the primary endpoint, and overall survival was included in the secondary endpoints.
Novartis announced that Kisqali is the sole CDK4/6 inhibitor, demonstrating an overall survival benefit irrespective of patient or disease characteristics.
Tislelizumab demonstrated non-inferior overall survival versus sorafenib in HCC patients.
Novartis announced the results of the Phase 3 RATIONALE 301 trial, demonstrating the non-inferior overall survival of tislelizumab compared to sorafenib in patients with untreated hepatocellular carcinoma (HCC).
The median overall survival in patients on tislelizumab was 15.9 months versus 14.1 months in patients on sorafenib.
Tislelizumab demonstrated a higher objective response rate versus sorafenib (14.3% versus 5.4%) and durable response (36.1 months versus 11.0 months). Median progression-free survival was 2.1 months versus 3.4 months in patients on sorafenib.
GSK
GSK presented Zejula's durable and sustained long-term progression-free survival data in ovarian cancer patients
GSK presented the long-term data of the phase III PRIMA study, demonstrating sustained and clinically-meaningful progression-free survival (PFS) when administered as maintenance therapy in patients with first-line ovarian cancer. GSK announced that the benefit was maintained across all subgroups, including BRCAm, HRd, and HRp groups.
In the HRd population, Zejula reduced the disease progression or death by 48% versus placebo. The probability of no disease progression or death was 30% in the Zejula arm compared to 17% in patients on placebo after four years.
The estimated durable PFS was 24% in the Zejula arm compared to 14% in patients on placebo.
In the HRp population, the risk of progression or death was reduced by 35% compared to placebo.
ASTRAZENECA
Imfinzi and tremelimumab with chemotherapy showed overall survival in Stage IV NSCLC patients
AstraZeneca announced four years of follow-up data of the POSEIDON Phase III trial. Imfinzi (durvalumab) plus four cycles plus tremelimumab showed an improvement in overall survival (OS) versus chemotherapy alone in patients with Stage IV metastatic non-small cell lung cancer.
The latest data showed that the combination improved the overall survival by 25% versus chemotherapy alone. Median OS was 14 months versus 11.7 months in patients on chemotherapy.
Extrapolation analysis showed improved OS with this combination in STK11, KEAP1, and KRAS-mutated NSCLC patients.
Imfizi plus chemotherapy improved overall survival benefit in biliary tract cancer.
AstraZeneca has presented the updated TOPAZ-1 Phase III trial, demonstrating the efficacy of Imfinzi (durvalumab) plus chemotherapy combination in patients with advanced biliary tract cancer.
Imfinzi, when administered in combination with gemcitabine plus cisplatin, reduced the risk of death by 24% versus chemotherapy alone. The median overall survival was 12.9 months versus 11.3 months in patients on chemotherapy. 23.6% of patients were alive after two years compared to 11.5% of patients on chemotherapy.
Tagrisso demonstrated sustained disease-free survival in EGFRm NSCLC
AstraZeneca announced the ADAURA Phase III trial demonstrating sustained disease-free survival (DFS) versus placebo in epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Tagrisso reduced the risk of disease recurrence or death by 77% in the primary analysis population and 73% in the overall trial population. The median DFS was nearly 5.5 years in the primary analysis and overall populations versus 21.9 months and 28.1 months in patients on placebo.
Tagrisso is irreversible EGFR-TKI and has treated more than 600,000 patients worldwide.
Enhertu showed tumor response in HER2-mutant metastatic non-small cell lung cancer.
AstraZeneca has announced the results of the DESTINY-Lung02 Phase II trial, demonstrating the efficacy of Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).
In the interim analysis of DESTINY-Lung02, patients administered with 5.4mg/kg or 6.4mg/kg dose of Enhertu showed meaningful activity. The objective response rate in patients treated with 5.4mg/kg was 53.8% and with 6.4mg/kg was 42.9%.
Enhertu is a HER2-directed antibody-drug conjugate.
Lynparza as a monotherapy and in combination with bevacizumab showed an overall survival benefit in ovarian cancer patients.
AstraZeneca announced the results of two Phase 3 trials, demonstrating the efficacy of Lynparza as monotherapy and in combination with bevacizumab in patients with advanced ovarian cancer.
The follow-up results of PAOLA-1 and SOLO-1 Phase III trials showed overall survival benefits.
In the PAOLA-1 trial, the median overall survival in Lynparza plus bevacizumab was 56.5 months versus 51.6 months in patients on bevacizumab alone in newly diagnosed advanced ovarian cancer patients irrespective of HRD status. Lynparza showed no statistically significant improvement. In HRD-positive patients, Lynparza plus bevacizumab reduced the risk of death by 38% compared to bevacizumab. 65.5% of patients on the combination therapy were alive after five years compared to 48.4 patients on bevacizumab monotherapy. The median progression-free survival was 46.8 months in the combination arm compared to 17.6 months in patients on bevacizumab alone.
In the SOLO-1 Phase III trial, Lynparza improved overall survival versus placebo in patients with BRCA mutated newly diagnosed advanced ovarian cancer. The risk of death was reduced by 45%; however, this is not statistically significant. The median OS was not reached in the Lynparza arm versus 75.2 months in patients on placebo.
GILEAD
Trodelvy improved OS in HR+/HER2 negative pre-treated breast cancer patients.
Gilead announced Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan) in patients with HR+/HER2- metastatic breast cancer, previously treated with chemotherapy and endocrine-based therapies.
The overall survival was increased by 3.2 months compared to chemotherapy. The primary endpoint, progression-free survival, was met earlier.
Trodelvy is a Trop-2-directed antibody-drug conjugate approved for TNBC and locally advanced or metastatic UC.
AMGEN
Amgen presented Lumakras, Vectibix combination data in KRAS G12-mutated colorectal cancer.
Amgen presented the updated Phase 1b CodeBreaK 101 study, demonstrating the efficacy of Lumakras (sotorasib) with Vectibix (panitumumab) combination data in KRAS G12-mutated colorectal cancer. The objective response rate was 30% in patients with chemo-refractory metastatic colorectal cancer (mCRC).
The trial included 40 patients with pre-treated KRAS G12C-mutated chemo-refractory mCRC. The median progression-free survival was 5.7 months. There was no difference observed between the right side and left side tumors.
KRAS is the most common mutation in patients with colorectal cancer, accounting for nearly 40% of all cases.
MERCK
Keytruda plus Lenvima showed no statistical significance versus Lenvima monotherapy in patients with liver cancer.
Merck presented the final analysis of the Phase-3 LEAP-002 trial, evaluating the efficacy of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) versus Lenvima monotherapy as first-line option for patients with unresectable hepatocellular carcinoma.
In the final analysis, the combination has not shown statistical significance in the overall survival. The median overall survival was 21.2 months in patients on Keytruda plus Lenvima combination versus 19.0 months in patients on Lenvima monotherapy.
Lenvima monotherapy is approved for unresectable hepatocellular carcinoma in the US, Eu, China, and Japan. The approval was based on Phase 3 REFLECT trial, in which Lenvima efficacy and safety were demonstrated versus sorafenib.
Merk announced 5-year survival data of Keytruda from two studies in patients with NSCLC.
Merck announced Keytruda (pembrolizumab) plus chemotherapy combination overall survival data versus chemotherapy alone as first-line therapy in patients with metastatic non-small cell lung cancer (NSCLC).
In KEYNOTE-189, the 5-year survival in Keytruda plus chemotherapy combination was 19.4% versus 11.3% in patients on chemotherapy alone. The median overall survival was 22.0 months in patients on Keytruda combination versus 10.6 months in patients on chemotherapy.
In KEYNOTE-407, the five-year survival rate of Keytruda plus carboplatin-paclitaxel or nab-paclitaxel was 18.4% versus 9.7% for chemotherapy. The median overall survival was 17.2 months versus 11.6 months in patients on chemotherapy.
Merck announced that Keytruda is the first immunotherapy that has shown five-year survival benefit, both as monotherapy and in combination as first-line treatment in NSCLC patients.