pembrolizumab

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer

Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test The approval is based on the P-III KEYNOTE-826 trial that demonstrated superior OS and PFS, ORR (68% vs 50%), mDOR …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer Read More »

Ultimovacs Reports Results of 24-month Follow-up Study of UV1 + Pembrolizumab for 1L Treatment of Metastatic Malignant Melanoma

Shots: In a P-I study, patients were treated initially for 14wks. with UV1 + pembrolizumab and patient in the first cohort had been followed for at least 24mos. from the start of their treatment, @ cut-off date of Oct 12, 2021 After @2yrs. follow up, OS (80%) in the first cohort of 20 patients. mPFS …

Ultimovacs Reports Results of 24-month Follow-up Study of UV1 + Pembrolizumab for 1L Treatment of Metastatic Malignant Melanoma Read More »

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer

Shots: The P-III KEYNOTE-826 trial evaluates Merck’s Keytruda (200mg, IV, q3w for up to 35 cycles) + Pt-based CT vs PBO + CT with/out bevacizumab in 617 patients aged b/w 22- 82yrs. with persistent, recurrent, or metastatic cervical cancer The results showed a 33% reduction in the risk of death; m-OS (24.4 vs 16.5mos.), m-PFS …

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer Read More »

Merck Enters into a Clinical Collaboration with Hookipa to Evaluate Keytruda (pembrolizumab) + HB-200 as 1L Treatment of Advanced Head and Neck Cancers

Shots: The companies collaborated to evaluate Hookipa’s HB-200 (arenaviral immunotherapeutic) + Merck’s Keytruda (anti-PD-1 therapy) in a P-II trial for patients with advanced HNSCC, based on an ongoing P-I/II trial of HB-200 for advanced HPV16+ cancers patients HB-201 monothx. showed an ORR (18%), m-PFS (3.45mos.) in heavily pretreated head & neck cancer patients. Preliminary data …

Merck Enters into a Clinical Collaboration with Hookipa to Evaluate Keytruda (pembrolizumab) + HB-200 as 1L Treatment of Advanced Head and Neck Cancers Read More »

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies

Shots: The companies collaborated to evaluate ADG106 + Keytruda in dose-escalation and expansion clinical study to treat advanced or metastatic solid tumors & hematological malignancies In preclinical studies, ADG106 showed antitumor activity and was well tolerated as a monothx. and in combination with other immuno-oncology therapies ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 …

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies Read More »

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, qd) vs sunitinib (50 mg, q4w) in a ratio (1:1:1) in 1,069 patients with advanced RCC The results demonstrated an improvement in PFS with a …

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma Read More »

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC

Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with RCC, following nephrectomy and resection of metastatic lesions The results demonstrated an improvement in DFS and were presented at ASCO 2021 with an anticipated PDUFA …

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma

Shots: The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected high-risk melanoma. The anticipated PDUFA date for the therapy is Dec 04, 2021 The trial met its 1EPs of RFS with no new safety signals observed. Based on this data, …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma Read More »

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma

Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint therapy across the US, Canada, EU & Australia The companies will responsible for internal costs with OncoSec covering the third-party costs. The trial is intended …

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma

Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA cSCC that is not curable by surgery or radiation Results: ORR (50%); CR (17%); PR (33%), 81% had DOR of 6mos. or longer, and 37% …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma Read More »

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021

Shots: The P-III KEYNOTE-564 evaluating Keytruda monothx (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) vs PBO in 950 patients with RCC, following nephrectomy & resection of metastatic lesions Results: @ median follow-up of 24.1 mos., 32% reduction in the risk of disease recurrence or death, a favorable trend …

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021 Read More »

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R

Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will supply Keytruda The companies plan to initiate a P-I/II trial to evaluate the safety, tolerability, and PK of combination therapy and is expected in ~6 to 9 mos. upon achieving …

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R Read More »

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs sunitinib in a ratio (1:1:1) in 1,069 patients with advanced RCC, demonstrated improved PFS, OS, and ORR The 2nd application is based on results from the P-III KEYNOTE-775/Study 309 trial …

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma Read More »

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Shots: The expansion cohort of P-l study involves assessing of mRNA-4157 + Keytruda (pembrolizumab) vs Keytruda monothx. in 10 patients with HPV (-) HNSCC and 17 patients with MSS-CRC, presented at the SITC 2020. Results: in the HPV(-) HNSCC group, ORR (50% vs 14.6%) with 2 patients achieving CR & 3 patients achieving PR; mPFS …

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL after at least one multi-agent CT regimen Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 3mos); ORR …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma Read More »

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots: The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.) Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV …

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan Read More »

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20 The 1EPs od the study will be ORR while the 2EPs include OS, PFS, [email protected], one-year survival …

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer Read More »