Immunomedics, Inc. announced positive results from cohort 1 of cisplatin-eligible patients in the pivotal phase II TROPHY U-01 study onits lead drug,Trodelvy (sacituzumabgovitecan-hziy), in metastatic urothelial cancer (mUC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
The interim results showed that Trodelvy achieved a 27% overall response rate and a 5.9-month median duration of response in heavily-pretreated patients with mUC. As of data cutoff on May 18, 2020, out of 31 responders, 8 had an ongoing response and remained on treatment. Results confirmed the interim findings and prior phase I/II study results showing that Trodelvy has significant activity and is safe in patients with heavily-pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI). Trodelvy received Fast Track Designation from the FDA forthis indication.
The company is planning to file a supplemental biologics license application (sBLA) in the fourth quarter of 2020 for mUC after receiving guidance from the FDA for the same. A new phase III TROPiCS-04 study in third-line mUC has been reviewed by the FDA and is under review by the European Medicines Agency. In fact, it is currently in the initiation phase.
Shares of Immunomedics have surged 304.2% year to date compared with the
industry’s growth of 2.9%.
We note that Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate (ADC) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. This indication wasapproved under accelerated approval based on tumor response rate and duration of response.Immunomedics plans to submit a sBLA to support the full approval of Trodelvy in the United States for the treatment of mTNBC in the fourth quarter of 2020 under the RTOR program. The company also plans to submit a marketing authorization application (MAA) to the European Medicines Agency in the first half of 2021.
The company also announced results from the confirmatory phase III ASCENT study, which showed that Trodelvy significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR) compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease.
Despite having received a median of four prior anticancer regimens, patients treated with Trodelvy in the ASCENT study showed a statistically significant and clinically meaningful improvement in OS with a median of 12.1 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.48. Trodelvy also demonstrated a statistically significant improvement in ORR (35%) and CBR (45%) compared to chemotherapy (5% and 9%, respectively).
Further, the company announced results from another study where patients with brain metastasis from breast cancer (BMBC) or recurrent glioblastoma (rGBM) were enrolled in the single-center study to receive a single intravenous dose of Trodelvy at 10 mg/kg one day before surgical resection. Tumor and corresponding serum were collected during surgery to measure their levels of SN-38 and its metabolites. In the study, Trodelvy delivered 150-fold and 40-fold the 50% inhibitory concentration (IC50) of SN-38 for BMBC and rGBM, respectively, and produced partial responses in both cohorts of brain cancer patients.
Zacks Rank & Stocks to Consider
Immunomedicscurrently carries a Zacks Rank #3 (Hold).
Some other top-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (
EBS Quick Quote EBS - Free Report) , Bio Techne Corp ( TECH Quick Quote TECH - Free Report) and Alimera Sciences Inc. ( ALIM Quick Quote ALIM - Free Report) . While Emergent sports a Zacks Rank #1, Bio Techne and Alimera carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here .
Emergent’s earnings estimates have increased from $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 86.4% year to date.
Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 11.1% year to date.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 24.8% year to date.
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