BMS
Opdivo for Resected Esophageal or Gastroesophageal Junction Cancer
Bristol Myers Squibb has presented the results of Phase 3 CHeckMate-577 trial in patients with resected esophageal or gastroesophageal junction cancer. Opdivo has shown meaningful improvement in progression-free survival compared to placebo in patients who were prior treated with neoadjuvant chemoradiation therapy and tumor resection.
Median disease-free survival was 22.4 months in the Opdivo arm compared to 11 months in patients who were on placebo. The median duration of treatment was ten months in patients who were on Opdivo compared to 9 months in the placebo arm.
Esophageal cancer is the six leading cause of cancer death. Approximately 508,000 patients were died in 2018 because of esophageal cancer. Squamous cell carcinoma accounts for 85% of the cases, and adenocarcinoma accounts for 15% of the cases.
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Opdivo + Cabometyx
Bristol Myers Squibb and Exelixis have presented the Phase 3 CheckMater-9ER trial. The study is intended to demonstrate improvement in overall survival and other endpoints in patients suffering from advanced renal cell carcinoma. The combination is compared with sunitinib; the risk of death was reduced by 40% vs. sunitinib. The median progression-free survival in Opdivo + Cabometyx arm was 16.6 months compared to 8.3 months in patients on sunitinib.
The duration of the response is 20.2 months in Opdivo + Cabometyx arm compared to 11.5 months in the sunitinib arm.
The trial is conducted in patients with previously untreated advanced or metastatic renal cell carcinoma.
Renal cell carcinoma accounts for 140,000 deaths worldwide. It is more common in men compared to women.
Opdivo is a programmed death-1 inhibitor. The drug has been approved for melanoma, NSCLC, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, and urothelial cancer.
NOVARTIS
Kisqali (ribociclib)
Novartis has announced that Kisqali achieved five out five on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for premenopausal women with HR+/HER2- advanced breast cancer (aBC). The score was based on the Phase III MONALEESA-7 trial. Kisqali achieved four out of five on the ESMO-MCBS scale in postmenopausal women.
Novartis has presented the additional data of Kisqali at the ESMO2020.
Treatment with Kisqali resulted in a reduction in the risk of death by 30% and 41% in the MONALEESA-3 and -7 trials. The trials were conducted in endocrine-resistant patients and were compared with standard endocrine therapy
Spartalizumab with Tafinlar and Mekinist
Novartis has presented the Phase COMBI-i trial data of spartalizumab combined with Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar + Mekinist alone.
The Phase III COMBI-I trial was conducted in treatment-naïve patients with advanced BRAF V600 mutation-positive cutaneous melanoma.
The median time of progression-free survival was 16.2 months in triple therapy compared to 12.0 months in the dual treatment (Tafinlar + Mekinist). The overall response rate was 68.5% in patients who were on spartalizumab + Tafinlar + Mekinist arm versus 64.2% in patients who were on Tafinlar + Mekinist arm.
Spartalizumab is a monoclonal antibody, blocks the human programmed death-1 receptor.
Piqray (alpelisib)
Novartis has presented the comparative data of Piqray + fulvestrant versus fulvestrant monotherapy in patients with HR+/HER2- advanced breast cancer.
The company has presented SOLAR-1 final analysis, demonstrating the improvement in the overall survival in patinets who were on Piqray plus fulvestrant treatment compared to fulvestrant alone.
The median overall survival was 39.3 months in Piqray + fulvestrant arm compared to 31.4 months in fulvestrant alone, an improvement of eight months. However, this has not met the prespecified threshold of statistical significance. Further, a median overall survival of 37.2 months was observed in patients with lung or liver metastases compared to 22.8 months in patients who were only on fulvestrant alone.
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ROCHE/GENENTECH
Tecentriq (atezolizumab)
Genentech presented the new data from the Phase III IMpassion031 study. Tecentriq, in combination with chemotherapy, improved complete response in patients with early triple-negative breast cancer.
Tecentriq is administered in combination with Abraxane (paclitaxel, followed by doxorubicin and cyclophosphamide) and is compared with placebo + paclitaxel. Tecentriq has demonstrated improvement in pathological complete response in patients with early triple-negative breast cancer. The pathological complete response was observed in 57.6% of patients who were in the Tecentriq arm compared to 41.1% in the placebo arm, an improvement of 16.5%.
MERCK
Lynparza (olaparib)
AstraZeneca and Merck have presented the 5-year data of Lynparza (olaparib) from the Phase-3 SOLO trial. The drug has shown long-term progression-free survival compared to placebo as a first-line treatment for advanced BRCA-mutated ovarian cancer patients who responded partly or entirely to platinum therapy.
During the five-year follow-up data, the risk of disease progression reduced by 67%, improved progression-free survival to 56 months compared to 13.8 months in the placebo arm. 48.3% of patients remained free from disease progression after five years, compared to 20.5% in the placebo arm.
Ovarian cancer is the eighth most common cancer worldwide, with 300,000 new patients diagnosed every year. 22% of patients with ovarian cancer have BRCA1/2 mutations.
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ASTRAZENECA
Imfinzi (durvalumab)
PACIFIC Phase III trial in NSCLC
AstraZeneca has presented the updated results from the PACIFIC Phase III trial of Imfinzi. The trial demonstrated sustained clinically meaningful overall survival (OS) and progression-free survival of Imfinzi in patients with stage III non-small-cell lung cancer who progressed after the treatment with concurrent chemoradiation therapy (CRT).
The results showed that the four-year overall survival rate is 49.6% in the Imfinzi arm compared to 36.3% in the placebo arm after CRT. The median overall survival was 47.5 months in the Imfinzi arm compared to 29.1 months in the placebo arm.
CASPIAN Phase III trial in SCLC
AstraZeneca has also presented the Phase III CASPIAN study trials, which demonstrated that more than three times patients who were Imfinzi plus chemotherapy were alive than chemotherapy alone. Progression-free survival was more than one year.
Lung cancer is the most common cancer and is the leading cause of cancer death. 85% of lung cancers are non-small cell lung cancers, and the remaining 15% are classified as small cell lung cancer.
Tagrisso (osimertinib)
AstraZeneca has presented the positive ADAURA Phase III trials of Tagrisso (osimertinib), demonstrated the improvement in the central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage epidermal growth receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
CNS recurrence is a common complication in the patients suffering from EGFRm NSCLC. Among the patients who had CNS recurrence, 38% of patients who were treated with Tagrisso had metastatic recurrence versus 61% in patients who were on placebo. There was a reduction of 82% reduction in the risk of CNS recurrence or death in patients who were on Tagrisso.
Tagrisso has received Breakthrough Designation from the US FDA for treating patients with early-stage EGFRm NSCLC after complete tumor resection. The product has been approved in the US, Japan, Europe, China, and other maor markets for EGFR T790M mutation-positive and EGFRm NSCLC.
SEATTLE GENETICS
Padcev (enfortumab vedotin)
Seattle Generics and Astellas Pharma have announced the Phase 3 trial results of Padcev in patients with locally advanced or metastatic urothelial cancer. The drug met the primary endpoint of overall survival compared to chemotherapy. The global EV-301 is intended to demonstrate the efficacy of Padvec in the advanced or metastatic urothelial cancer vs. chemotherapy.
The overall survival was improved significantly in the Padcev arm compared to the chemotherapy, reduction in risk of death was decreased by 30%. Significant improvement in the overall survival was observed, with a 39% reduction in risk of disease progress or death.
Approximately 580,000 patients have bladder cancer across the world. 90% of bladder cancers are urothelial cancers. 90% of the patients do not respond to PD-1 or PD-L1 inhibitors after a platinum based-chemotherapy.
TAKEDA
Alunbrig (brigatinib)
Takeda has announced the Phase 3 ALTA 1L results, which demonstrated the efficacy of Alunbrig in ALK+ NSCLC. The trial showed that Alunbrig significantly prolonged intracranial disease progression compared to crizotinib in patients with ALK + NSCLC.
For the progression of intracranial disease, it took 24 months in the Alunbrig arm compared to 5.6 months in the crizotinib arm. The overall progression-free survival was 24 months in the Alunbrig arm compared to 5.5 months in the crizotinib arm.
Alunbrig is approved in the U.S. and Europe for treating patients with ALK-positive NSCLC, previously not treated with ALK inhibitor.
BAYER
Vitrakvi (larotrectinib)
Bayer has presented the clinical trial data of Vitrakvi (larotrectinib) in patients with TRK fusion cancers including lung and thyroid cancers.
In the expanded data, Vitrakvi demonstrated overall response rate (ORR) of 78%, 19% of patients showed complete response, 59% of patients showed partial response, 13% with stable disease in TRK fusion cancers. Median progression-free survival was 36.8 months, 12-month estimated median overall survival (OS) was achieved in 90% of patients and 24-month estimated overall survival rate was 83%.
Also read: Merck announced trial results of gefapixant in patients with refractory or unexplained chronic cough
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