Penpulimab

Generic Name
Penpulimab
Brand Names
-
Drug Type
Biotech
Chemical Formula
-
CAS Number
2350298-92-7
Unique Ingredient Identifier
IBS1BZ4E4I
Indication

适用于至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤成人患者。

Associated Conditions
-
Associated Therapies
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onclive.com
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China's NMPA Accepts sNDA for Penpulimab Plus Anlotinib for Advanced HCC

NMPA accepted an sNDA for penpulimab plus anlotinib as first-line treatment for advanced HCC, based on APOLLO/ALTN-AK105-III-02 study data showing improved PFS (6.9 vs 2.8 months) and OS (16.5 vs 13.2 months) compared to sorafenib. The combination was tolerable with manageable safety profiles.
ascopost.com
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Penpulimab Combination Therapy for First-Line Treatment of Hepatocellular Carcinoma

NMPA accepted penpulimab's sNDA for first-line advanced HCC, marking its fifth indication. Supported by ALTN-AK105-III-02 trial, penpulimab + anlotinib reduced progression/death risk by 47% vs sorafenib, and death risk by 31%. No new safety signals noted. Penpulimab's combination therapy for metastatic nasopharyngeal carcinoma also accepted by NMPA and FDA.
biospace.com
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Akeso's Penpulimab Combination Therapy for First-line Treatment of Hepatocellular

Akeso's penpulimab, a PD-1 monoclonal antibody, in combination with anlotinib, has had its supplemental new drug application accepted by China's NMPA for first-line treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, supported by the ALTN-AK105-III-02 study, which showed significant improvements in progression-free survival and overall survival in HCC patients compared to sorafenib.
ascopost.com
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Rachna Shroff on Advanced Hepatocellular Carcinoma: Anlotinib Plus Penpulimab vs Sorafenib

The APOLLO Study in China combined anlotinib (TKI) with penpulimab (anti-PD1) in advanced hepatocellular carcinoma, showing improved progression-free survival (6.9 months vs. 2.8 months) and overall survival (16.5 months vs. 13.2 months) compared to sorafenib, with manageable safety profiles. The study's results contrast with negative US trials, suggesting potential regional differences in treatment efficacy.

Anlotinib and penpulimab - to the Moon and beyond for advanced HCC?

The Phase III APOLLO trial presented at ESMO 2024 showed Chia Tai Tianqing's Focus V (anlotinib) plus Akeso's penpulimab significantly improved progression-free survival (PFS) and overall survival (OS) in first-line advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck's Keytruda in the LEAP-002 trial. Elevar Therapeutic's PD-1 IO camrelizumab and TKI rivoceranib also showed benefits in the CARES-310 trial but with more adverse events. Despite these results, Roche's Tecentriq with bevacizumab remains the first-line standard of care in aHCC, predicted to generate $980m in sales by 2029.

Anlotinib and penpulimab gather attention in HCC with APOLLO results

The APOLLO trial at ESMO 2024 showed Chia Tai Tianqing's Focus V and Akeso's penpulimab significantly improved PFS and OS in advanced hepatocellular carcinoma (aHCC) compared to sorafenib, with a manageable safety profile. This contrasts with the failure of Merck & Co's Keytruda in the LEAP-002 trial. Competitive IO-TKIs like Elevar Therapeutics' camrelizumab and rivoceranib also showed benefits but with more TRAEs. Roche's Tecentriq with bevacizumab remains the first-line standard-of-care in aHCC, posing a challenge to new IO-TKI combinations.
benzinga.com
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Gearing up for the European Society for Medical Oncology (ESMO24) Congress with OBiS

OBiS Insights pre-meeting ESMO24 report profiles 275 new, unapproved cancer drugs, classified as 40% antibody-based, 37% small molecule, and 23% mixed bag. The report excludes drugs not in abstract titles and will update during the conference. 43% of these drugs were discussed at recent ASCO24 meetings.
prnewswire.com
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Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its ...

Akeso, Inc. to present results from 13 clinical studies on cadonilimab, ivonescimab, ligufalimab, and penpulimab at ESMO Congress 2024, covering advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Key findings include ivonescimab's efficacy in mCRC and TNBC, and a Phase III study comparing anlotinib plus penpulimab versus sorafenib for HCC.
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