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Subcutaneously Injected PD-L1 Antibody Envafolimab (KN035) Obtained Its Second Orphan Drug Designation From The U.S. FDA
prnasia
June 30, 2021
Alphamab Oncology announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to envafolimab (KN035), a recombinant humanized PD-L1 single-domain antibody independently invented by Alphamab Oncology ...
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Merck’s KEYTRUDA Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Patients With Cervical Cancer
americanpharmaceuticalreview
June 23, 2021
Merck announced that the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin) with or without bevacizumab ...
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Anti-PD-L1 monoclonal antibody shows promise in lung cancer patient
europeanpharmaceuticalreview
May 31, 2021
In a Phase III trial sugemalimab meaningfully improved progression free survival in patients with stage III non-small cell lung cancer (NSCLC).
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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® in Combination With Chemotherapy as First-Line Treatment for Patients With Esophageal Cancer or GEJ Adenocarcinoma
americanpharmaceuticalreview
May 25, 2021
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum- and ...
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Transcenta Announces Updated Clinical Data from Phase I Study of pH-Dependent PD-L1 Antibody MSB2311 to Be Presented at the 2021 ASCO Annual Meeting
prnasia
May 14, 2021
Transcenta Holding Limited, a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, today announced that the updated phase I clinical data on the ...
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Transcenta Received IND Clearance from US FDA for Initiating Phase I Clinical Trial for its Bi-functional Anti-PD-L1/TGF-β Antibody TST005
prnasia
April 21, 2021
Transcenta Holding Limited (Transcenta), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, today announced that it has received clearance of ...
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Roche’s Tecentriq improves disease-free survival in early lung cancer
pharmatimes
March 22, 2021
Roche’s PD-L1 inhibitor Tecentriq significantly improved disease-free survival (DFS) in patients with resectable, early stage non-small cell lung cancer (NSCLC), according to newly published Phase III data.
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Immutep Expands Part B of TACTI-002 Study
americanpharmaceuticalreview
March 10, 2021
Immutep has decided to expand Part B of its TACTI-002 Phase II trial, under the study’s Simon’s two- stage clinical trial design. Immutep has commenced recruitment of an additional 13 second line Non-Small Cell Lung Cancer (NSCLC) patients ...
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Innovent Announces First Patient Outside China Dosed in the Phase 1 Clinical Trial of Anti-CD47/PD-L1 Bispecific Antibody
prnasia
March 01, 2021
Innovent Biologics, Inc. announces that the first patient outside China has been successfully dosed in a Phase 1 clinical trial of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322).
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FDA Approves Libtayo
americanpharmaceuticalreview
February 23, 2021
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high ...