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Enhertu beats Kadcyla in head-to-head breast cancer trial


29/11/2021 | 3 minutes to read

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Positive high-level results from the DESTINY-Breast03 Phase 3 trial showed that Enhertu (trastuzumab deruxtecan), the AZ and Daiichi Sankyo HER2-directed ADC demonstrated superiority over Kadcyla (trastuzumab emtansine). At a planned interim analysis, the IDMC concluded that the trial met the primary endpoint of PFS showing a highly statistically significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

Enhertu also showed a strong trend toward improved OS compared to Kadcyla in a key secondary endpoint, although the OS data are still immature. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events. Data will be shared at an upcoming medical meeting and filed with regulators.

The results could move Enhertu further to the front in the treatment line for HER2-positive breast cancer, as it is already approved for patients who have received two or more previous anti-HER2 therapies.


Polivy meets the endpoints in Phase 3 trial for first line DLBCL 

Polivy polatuzumab vedotin by Genentech in combination with Rituxan rituximab and cyclophosphamide, doxorubicin and prednisone significantly improved progression free survival in a Phase 3 study of previously untreated DLBCL patients when compared with standard of care. Polivy, which was developed using ADC technology from Seagen, is marketed for refractory DLBCL after at least two prior therapies.


Seagen and Remegen announced exclusive global license agreement for disitamab vedotin

Seagen and RemeGen announced that the two companies have entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC. Disitamab vedotin combines the drug-linker technology originally developed by Seagen with RemeGen’s novel HER2 antibody exhibiting higher affinity and an increased internalization rate as compared to trastuzumab in preclinical models. Disitamab vedotin received FDA Breakthrough Therapy designation in 2020 for use in second-line treatment of patients with HER2-expressing, locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy.  Seagen will make a $200 million upfront payment to exclusively license rights to disitamab vedotin for global development and commercialization, outside of RemeGen’s territory. RemeGen will retain development and commercialization rights for Asia, excluding Japan and Singapore. Seagen will lead global development and RemeGen will fund and operationalize the portion of global clinical trials attributable to its territory. RemeGen will also be responsible for all clinical development and regulatory submissions specific to its territory. Seagen will pay RemeGen up to $2.4 billion in potential total milestone payments based upon the achievement of specified development, regulatory and commercialization goals across multiple indications and products. RemeGen will be entitled to a tiered, high single digit to mid-teen percentage royalty based on net sales of disitamab vedotin in Seagen’s territory.

Abclon to develop ADCs using linker technology from Korean Abtis

Abclon has signed a memorandum of understanding with Abtis to co-develop a new ADC. The collaboration will combine Abclon’s ability to discover antibodies with Abtis’s Abclick ADC linker technology. Unlike the current site-specific ADC linker technologies, Abclick combines drugs to two specific amino acids without producing any variants of natural antibodies. As a result, its drug antibody ratio is easily adjustable, enjoying an advantage in establishing CMC and economic efficiency. The partners will begin by discovering antibodies that bind to specific drugs and prioritize planning the research. Financial terms, clinical timelines and indications were not disclosed.

Navrogen gains financing from Moulder Family Office

The newest company in the portfolio of Lonnie Moulder’s Tellus BioVentures family office is Navrogen, which announced that it has raised $3 million to develop its Humoral Immuno-Oncology (HIO) discovery platform. The lead program for the company, which is developing therapies targeting humoral immunosuppressed cancers and immune-related disorders, is a preclinical HIO-refractory, anti-mesothelin ADC. Navrogen also has an NK cell activator platform.

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