Poziotinib’s Shift Of Focus To HER2 May Increase Approval Chances

Potential First-Line Therapy

Encouraging new data for Spectrum/Hanmi’s poziotinib presented at ESMO may increase the chances of approval for the pan-HER inhibitor as a possible first-line therapy for NSCLC with the HER2 exon 20 insertion mutation, although the patient population is limited.

positive
No Specific Approved NSCLS Therapy So Far For HER2 Exon 20 Insertion Mutation • Source: Alamy

Spectrum Pharmaceuticals Inc. presented positive data from Cohort 4 of the Phase II ZENITH20 study with poziotinib in the first-line setting in non-small cell lung cancer (NSCLC) patients with HER2 exon 20 insertion mutations at the recent European Society for Medical Oncology (ESMO) Congress, showing the drug's potential in an area with high unmet need and few available treatment options.

More from Clinical Trials

UK Promises To ‘Turbo-Charge’ Clinical Trials As Tariff Threat Remains

 

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

PureTech Weighs Up Pros And Cons Of Going Private

 
• By 

The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.

Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
• By 

Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By 

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

More from R&D

Epsilogen Hits Antibody Acquisition Trail With TigaTx Takeover

 
• By 

Following the near-total dominance of IgG antibodies, the UK group is backing the potential of IgA and IgE-based therapies to transform cancer treatment with the purchase of US-headquartered TigaTx.

What Is Fuelling Cell And Gene Therapies In India?

 
• By 

Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?

Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
• By 

Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.