On August 27, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, and University College London (UCL) reported that data published online in Cell show that the Decipher Prostate Genomic Classifier predicts which patients with metastatic cancer are likely to benefit from treatment intensification with the chemotherapy docetaxel and which are not likely to benefit and can therefore avoid unnecessary toxicity (Press release, Veracyte, AUG 27, 2025, View Source [SID1234655520]). The findings—from the randomized, prospective, Phase 3 STAMPEDE trial—are the first to be published showing that a gene expression test can help clinicians better personalize chemotherapy decisions for patients with metastatic prostate cancer.

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Globally, nearly 1.5 million new cases of prostate cancer are diagnosed each year and the disease accounts for a fifth (nearly 400,000) of all cancer-related deaths in men, with these numbers expected to increase over the next two decades.1,2 In the United States, nearly 315,000 patients will be diagnosed with prostate cancer this year and it is the second-leading cause of cancer deaths among men.3 Most prostate cancer deaths occur in patients who first presented with advanced or metastatic disease—a group that has been growing faster in recent years in the U.S., compared to those presenting with localized disease.3

"Our findings suggest that the Decipher Prostate test may provide an important new tool to help guide treatment decisions for the growing population of patients with metastatic prostate cancer," said Professor Gerhardt Attard, director of UCL Cancer Institute and STAMPEDE trial co-investigator. "Treatment intensification with docetaxel, in addition to standard-of-care androgen deprivation therapy, is shown to improve survival for patients with metastatic prostate cancer. However, response rates vary and clinicians have had limited tools to identify who will likely benefit and who will not. Our results demonstrate the Decipher test’s ability to make this distinction."

The study involved 1523 patients with high-risk or metastatic prostate cancer who were randomized to standard-of-care treatment with androgen deprivation therapy (ADT) or to chemotherapy plus ADT. Patients were then followed for a median of 14 years. Among the 832 patients with metastatic prostate cancer, those with higher Decipher Prostate scores had improved survival benefit (HR 0.64, 95% CI 0.48-0.86) from docetaxel, while those with lower Decipher scores did not (HR 0.96, 95% CI 0.71-1.30; biomarker-treatment interaction p=0.039).

The findings remained consistent, regardless of each patient’s metastatic disease volume. This is important because current clinical practice favors use of docetaxel in patients with high- but not low-volume disease.

"The Decipher Prostate test’s ability to help guide treatment for patients with localized prostate cancer has already been established in dozens of peer-reviewed publications and it is the only gene expression test to achieve ‘Level I’ evidence status in the most recent NCCN Guidelines* for prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "This new publication provides important clinical evidence from a Phase 3 trial that supports expanded use of our test to patients with metastatic cancer—an area where there is a clear unmet need."

Veracyte began making the Decipher test for metastatic prostate cancer broadly available to clinicians in the U.S. in June 2025. The expanded-use test was developed through an ongoing collaboration between Veracyte and University College London.

"The recent introduction of the Decipher test for metastatic prostate cancer reinforces the power of our Veracyte Diagnostics Platform. This platform helps harness our whole-transcriptome data-generation capabilities and our commitment to partnering with the research community to advance cancer understanding and innovation. Ultimately, our goal is to further help improve patient care," said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.

For the current study, Veracyte performed whole-transcriptome analysis of all prostate samples. In addition to the commercially available Decipher Prostate test, other research-use-only gene signatures were evaluated. One notable finding was that metastatic tumors with both a high Decipher Prostate test score and a PTEN-inactive gene signature had the greatest benefit from the addition of docetaxel, suggesting potential opportunities to enable further-personalized patient care in the future.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

On August 27, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in September (Press release, RAPT Therapeutics, AUG 27, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-multiple-upcoming-investor [SID1234655519]):

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2025 Wells Fargo Healthcare Conference – Fireside chat on Wednesday, September 3, 2025 at 12:45 p.m. ET
Cantor Global Healthcare Conference 2025 – Fireside chat on Thursday, September 4, 2025 at 1:00 p.m. ET
H.C. Wainwright 27th Annual Global Investment Conference – Fireside chat on Tuesday, September 9, 2025 at 9:00 a.m. ET
Stifel 2025 Virtual Immunology & Inflammation Forum – Presentation on Monday, September 15, 2025 at 9:30 a.m. ET
To access the live webcasts or subsequent archived recordings of the fireside chats and presentation, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On August 27, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will be participating in the following investor conferences in September (Press release, ORIC Pharmaceuticals, AUG 27, 2025, View Source [SID1234655518]):

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Citi’s 2025 Biopharma Back to School Summit – Participating in a fireside chat on Wednesday, September 3, 2025, at 4:00 p.m. ET. Management will also be participating in one-on-one meetings.
2025 Wells Fargo Healthcare Conference – Participating in a fireside chat on Thursday, September 4, 2025, at 2:15 p.m. ET. Management will also be participating in one-on-one meetings.
Cantor Global Healthcare Conference 2025 – Participating in a fireside chat on Friday, September 5, 2025, at 8:35 a.m. ET. Management will also be participating in one-on-one meetings.
Morgan Stanley 23rd Annual Global Healthcare Conference – Participating in one-on-one meetings on Tuesday, September 9, 2025.
Baird 2025 Global Healthcare Conference – Participating in a fireside chat on Wednesday, September 10, 2025, at 1:25 p.m. ET. Management will also be participating in one-on-one meetings.
Webcasts of the fireside chat discussions will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.

On August 27, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported the completion of its Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with acute myeloid leukemia (AML) (Press release, Moleculin, AUG 27, 2025, View Source [SID1234655517]). Database lock for the trial is expected by the end of September, with the final clinical study report (CSR) projected to be published in early Q1 2026.

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In total, 22 subjects were enrolled in the trial, with all subjects (1L-7L) who received AnnAraC per protocol having completed their efficacy evaluations (n=20). The updated overall survival (OS) data reveal the following:

Median OS for Complete Remissions (CR): 15 months (n=8) with 4 subjects alive at study close
Median OS for the intent to treat (ITT) Population (1L-7L): 9 months (n=22; 13 subjects experienced an event, 9 subjects censored)
Median OS for 2L Efficacy Evaluable Population: 12 months (n=9)
"Industry publications1 note that the typical OS for relapsed AML patients is roughly 4-6 months, these results highlight a remarkable improvement, exceeding expectations by 30% or more," said Walter Klemp, Chairman and CEO of Moleculin Biotech.

As previously reported, 8 subjects in the ITT population of 22 (36%) achieved a complete remission (CR) following treatment with AnnAraC. Among the subjects treated in the second line (2L) setting (n=10), the CR rate (the same primary efficacy endpoint as in the ongoing Phase 2B/3 pivotal MIRACLE trial), was 50%. Median durability for the 8 subjects achieving a CR was 10 months and continuing at the end of the study. CR durability ranged from 2 months to 22 months. CRs were achieved in subjects with a variety of prior treatments, including traditional 7+3 and venetoclax regimens.

"We are glad to finally be in a position to close out our last Phase 2 AML trial, MB-106 by having completed follow-up on all subjects – some with durable CRs continuing – with database lock expected by the end of next month. While still technically preliminary, we are extremely pleased with the results of the MB-106 trial and look forward to the final CSR. These 2L data formed the basis for the design of the Phase 2B/3 pivotal MIRACLE trial with which we aim to gain eventual approval of Annamycin to serve the unmet need in 2L AML," added Walter Klemp, Chairman and CEO of Moleculin. "We continue to see meaningful, positive trends across all data points, particularly in overall survival and durability. Of note, an 80+ yr old subject who achieved a CR with one cycle of Annamycin and then received two maintenance cycles of Annamycin finally relapsed after 600+ days. He then received a fourth round of Annamycin under compassionate use and is now back in remission. These data are very exciting and continue to give us hope that Annamycin has the potential to address the significant unmet need for safe and effective therapies for R/R AML. We also need to reemphasize that we have not seen any cardiotoxicity in any of the subjects to date, a key aspect of Annamycin."

"We can now also report that 50% of subjects achieving CR moved on to a curative bone marrow transplant, which is the most sought-after goal of any induction therapy in AML," Mr. Klemp continued. "The results we have seen in 2L patients are better than any drug ever approved for second line AML and more than double the average for the last five drugs approved for 2L use."

"Looking ahead, we are focused on driving Part A of our Phase 3 MIRACLE trial forward and remain on track recruit the first 45 enrolled patients before the end of this year on which safety and efficacy will be unblinded. The final data from MB-106, coupled with the expected data from the MIRACLE trial will be invaluable as we continue to unlock the full potential of Annamycin for the treatment of AML," concluded Mr. Klemp.

The median age of subjects in MB-106 is 68 years. A total of 18 subjects had relapsed/refractory AML and 4 subjects were first line treatment. Two subjects discontinued early due to allergic reactions. All subjects who completed treatment had undergone post therapy disease response assessments (bone marrow assessment and/or peripheral blood evaluation) (Day 15 or later). No clinically significant signs of cardiotoxicity were noted during or after treatment in any of the subjects enrolled. The combination was well tolerated with myelosuppression and infections being the main adverse events (AEs). All data from MB-106 is preliminary and subject to change.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This global Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) includes sites in the US, Europe and the Middle East. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

On August 27, 2025 Merck reported that the first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evaluating the efficacy and safety of investigational patritumab deruxtecan (HER3-DXd) versus investigator’s choice of treatment in patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease progression following endocrine and CDK4/6 inhibitor therapy in either the adjuvant or first-line metastatic settings (Press release, Merck & Co, AUG 27, 2025, View Source [SID1234655516]).

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Patritumab deruxtecan is a specifically engineered HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed jointly by Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada).

While survival rates are high for those diagnosed with early-stage breast cancer, only about 30% of patients initially diagnosed with advanced disease or having metastatic progression are expected to live five years following diagnosis.1 Patients with HR positive, HER2 negative metastatic breast cancer experience poor outcomes if they progress following initial treatment, highlighting the need for additional options.2

"Despite significant development in the treatment landscape, HR positive, HER2 negative metastatic breast cancer is a highly complex and challenging disease with an overall poor prognosis," said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. "The promising clinical activity observed in our early phase studies including ICARUS-Breast01 suggest that patritumab deruxtecan has the potential to become a meaningful new treatment option for this specific type of breast cancer."

"The initiation of HERTHENA-Breast04 demonstrates our ongoing commitment to researching innovative approaches that may help treat some of the most challenging cancers," said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "These patients need new options, and we continue to pursue cutting-edge science to develop therapies that may lead to improved treatment outcomes."

The initiation of HERTHENA-Breast04 is based on results from ICARUS-Breast01 and a phase 1/2 breast cancer trial previously published in Journal of Clinical Oncology in June 2022, where patritumab deruxtecan showed promise in patients with metastatic breast cancer.

About HERTHENA-Breast04

HERTHENA-Breast04 is an open-label, randomized, phase 3 trial evaluating the safety and efficacy of patritumab deruxtecan (5.6 mg/kg) monotherapy versus physician’s choice of treatment in adult patients with unresectable locally advanced or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine and CDK4/6 inhibitor therapy. Patients in the trial should not be eligible to receive additional endocrine therapy and should not have received chemotherapy or an ADC for advanced or metastatic disease. Further, patients must have experienced disease progression on first-line endocrine and CDK4/6 inhibitor therapy in the advanced or metastatic setting or relapse on or within 24 months of adjuvant endocrine and CDK4/6 inhibitor therapy.

Patients will be randomized 1:1 to receive patritumab deruxtecan or physician’s choice of treatment, consisting of either chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, liposomal doxorubicin) or HER2 directed ADC (trastuzumab deruxtecan). Randomization will be stratified by HER2 expression and treatment intent (chemotherapy versus trastuzumab deruxtecan), HER3 expression (low versus high per IHC) and presence of visceral disease.

The dual primary endpoints of HERTHENA-Breast04 are progression-free survival by blinded independent central review and overall survival. Secondary endpoints include objective response rate, duration of response and safety.

HERTHENA-Breast04 will enroll approximately 1,000 patients across Asia, Europe, North America, and South America. For more information, please visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

More than 2 million cases of breast cancer were diagnosed in 2022, with approximately 670,000 deaths globally.3 While survival rates are high for those diagnosed with early-stage breast cancer, only about 30% of patients initially diagnosed with advanced disease or having metastatic progression are expected to live five years following diagnosis.1

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (as measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).4,5 Patients with HR positive, HER2 negative metastatic breast cancer experience poor outcomes if they progress following initial treatment, highlighting the need for additional options.2

About HER3

HER3 is a member of the HER family of receptor tyrosine kinases.6 HER3 is broadly expressed in about 90% of breast tumors.7,8,9 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival.10,11 There is currently no HER3 directed therapy approved for the treatment of any cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

About the Patritumab Deruxtecan Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of patritumab deruxtecan across multiple cancers. Trials in combination with other anticancer medicines also are underway.