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Padcev plus Keytruda under FDA Priority Review for urothelial cancer

Sotio Biotech

6/3/2023 | 3 minutes to read

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Updated data from the Phase 3 DESTINY-Breast03 study of anti-HER2 ADC Enhertu fam-trastuzumab deruxtecan-nxki against HER2 ADC Kadcyla ado-trastuzumab emtansine are even stronger than the interim data that led to Enhertu’s approval in the second-line metastatic breast cancer setting.


Strong Enhertu data continue with DESTINY-Breast03 readout at SABCS 

The updated data presented at the San Antonio Breast Cancer Symposium showed treatment with Enhertu led to a 36% reduction in the risk of death vs. Kadcyla, although median OS had not yet been reached in either arm of the trial. The updated mPFS was 28.8 months for Enhertu vs. 6.8 months for Kadcyla, a risk reduction of 67%. 

TROP2 ADC shows numerical advantages over Trodelvy

Initial data from Daiichi and AZ’s TROP2-targeted ADC shows some numerical advantages over Phase 3 data from Gilead’s Trodelvy in hormone receptor-positive, HER2-low or -negative mBRCA. But the two show little difference so far in TNBC. In the HR-positive, HER2-low or -negative setting in the Phase 1 TROPION-PanTumor01 study, datopotamab deruxtecan showed a numerically superior ORR and mPFS vs. data reported by Gilead in Phase 3 TROPiCS-02 of Trodelvy sacituzumab govitecan. However, most of the reported efficacy metrics were similar between the two ADCs in TNBC. The only measure where datopotamab could have an advantage is in DOR, where it showed a median DoR of 16.8 months vs. 6.3-7.7 months across two different TNBC trials of Trodelvy.

Magenta gains on its MGTA-117 data presented at ASH conference 

ASH data from Magenta Therapeutics sent the biotech’s shares up 56% on the promise of a less toxic, targeted conditioning agent for stem cell transplants to expand the eligible transplant population. The company said the preliminary Phase 1/2 data in 15 patients show MGTA-117, an ADC that binds CD117 that has a favorable tolerability profile, adding that in 1H23 it hopes to transition to patients with transplant-eligible relapsed/refractory AML and MDS. 

Padcev plus Keytruda combo under priority review in urothelial cancer

FDA set a PDUFA date of April 21, 2023, for Padcev enfortumab vedotin-ejfv from Seagen and Astellas Pharma and Keytruda pembrolizumab to treat first-line locally advanced or metastatic urothelial cancer which, if approved, would be the first of an ADC and immunotherapy to treat the disease. The combination was granted breakthrough therapy designation in February 2020. 

EU approval of Zynlonta triggers $50M milestone for ADC Therapeutics

ADC Therapeutics will receive a $50 million milestone from Swedish Orphan Biovitrum tied to the European Commission’s conditional approval of Zynlonta loncastuximab tesirine-lpyl, the partners’ ADC to treat relapsed or refractory DLBCL. In April, FDA granted accelerated approval to Zynlonta, which targets CD19. SOBI in-licensed territorial rights to the product in a June deal for $55 million up front.


Amgen and LegoChem entered into a five-target ADC deal

For the second time in as many days, a Western biopharma has reached into Asia to gain access to a basket of ADCs. Amgen is paying an undisclosed amount up front to LegoChem Biosciences to research, develop and commercialize ADCs against five undisclosed targets using the Korean biotech’s ConjuAll platform. Including milestones, the deal is worth almost $1.3 billion.

ADC play Dantari debuts with $47 million led by Westlake 

Dantari launched with $47 million raised in a series A round led by Westlake Village BioPartners. Other investors included Corner Ventures, Alexandria Venture Investments and Caltech. The company’s T-HDC platform allows for high capacity drug-antibody ratios for its ADCs, with tuneable release of the chemotherapy. In parallel, the California-based biotech also named Richard Markus as president and CEO.

Enlaza debuts with $61M, covalent targeting biologics platform

Enlaza Therapeutics raised a $61 million seed round led by Avalon Ventures, with participation from Lightspeed Venture Partners, Frazier Life Sciences and Samsara BioCapital, to develop biologics that form covalent bonds with targets to increase target occupancy while limiting systemic exposure. The technology, developed in the lab of UCSF uses unnatural amino acids to enable covalent bond formation between a compound and its target, and can be applied to a diverse range of modalities including ADCs and targeted radiotherapies. 

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