Wednesday, June 5, 2019

Daily Update - June 5th, 2019

Regulatory -

ImmunoGen shares tank (again) after the FDA nixes a shot at an OK for its armed antibody in wake of a failed PhIII
Endpoints News
- ImmunoGen was trying to use their subset data of patients overexpressing FRa, but the FDA just rejected that attempt and is instead asking for a new Phase III trial.  If stock price is any indication, this is not good news for them

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
FDA Press Release
- The FDA has been trying to make novel treatments available to more patients outside of the target audience of these trials.  They are pursuing this despite the mixed results seen so far

Clinical Results - (Its an ASCO party!)

Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting
Daiichi Sankyo Press Release
- Daiichi shows positive data for their 3rd ADC candidate, DS-1062, targeting  TROP2.  The data demonstrate that DS-1062 is safe and ready to progress into the dose escalation stage of the study

Ado-trastuzumab emtansine effective, safe in HER2-amplified salivary gland cancers
HemOnc Today
- Kadcyla continues to impress in new indications.  In this study the primary cohort of salivary gland cancer patients showed significant response enabling early meeting of primary endpoint, and immediate expansion into dose escalation phase of study

Mersana Presents Interim Phase 1 Data for XMT-1536 at the 2019 American Society of Clinical Oncology Annual Meeting
Mersana Press Release
- Mersana is releasing their clinical results for XMT-1536 at ASCO.  It looks like the treatment is well tolerated at the 20 mg/m2 dose.  Also the disease control rate was determined to be 61% in NSCLC and 71% in ovarian cancer

Seattle Genetics and Astellas Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer
SeaGen Press Release
- SeaGen shows a 44 percent response rate in patients and is full speed ahead for a BLA by the end of the year.  In related news, John Carroll interviewed SeaGen CEO Clay Siegall about this release and SeaGen more broadly.  Find that interview here

Seattle Genetics Announces Additional Analyses of ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials of ADCETRIS® (Brentuximab Vedotin) at the 2019 ASCO Annual Meeting
SeaGen Press Release
- And the second press release of the day shows that Adcetris continues to expand its indications with two more studies showing efficacy in Hodgkins and non-Hodgkins lymphoma after 3 years

Thats it for today. There are always more coming down the pike. Is there something I missed? Contact me. [email protected]

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