On June 2, 2025 PanGIA Biotech, a leader in non-invasive cancer diagnostics, reported findings at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from a prospective, multi-center validation study evaluating its AI-powered, urine-based platform for early-stage prostate cancer detection (Press release, PanGIA Biotech, JUN 2, 2025, View Source [SID1234653653]).

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The study, Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), is the first to clinically validate PanGIA’s novel approach—pairing proprietary chemistry with machine learning to detect cancer-specific biosignatures from a single, non-invasive urine sample.

"This study confirms what we’ve believed from the start: there’s power in non-invasive, data-driven diagnostics," said Holly Magliochetti, CEO of PanGIA Biotech. "Our platform helps clinicians detect prostate cancer when intervention is most effective—without costly or invasive procedures."

Key findings presented included:

Study Cohort: 197 biopsy-confirmed prostate cancer patients and 84 healthy controls.

Classifier Performance: Achieved an F1 score of 0.843 with a recall of 0.967 in distinguishing cancer from non-cancer subjects.

Gleason Score Cohorts: Maintained high recall (>0.89) across Gleason scores 6 through 10, with F1 scores ranging from 0.799 to 0.838.

Non-Invasive Advantage: Demonstrated strong performance in detecting intermediate- and low-grade cancers, offering a less invasive alternative to traditional diagnostics.
Unlike invasive biopsies or blood-based tests that often miss early-stage cases, PanGIA’s approach analyzes urinary biosignatures using proprietary AI models—eliminating the need for sequencing and enabling cost-effective, globally scalable testing.

Previously published in The Analyst, a journal of the Royal Society of Chemistry¹, the PanGIA platform is designed for diverse healthcare environments and holds promise for broad global adoption.

On June 2, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new clinical results from the PREDICT DNA and SCANDARE studies highlighting the capabilities of its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test for monitoring and predicting neoadjuvant therapy (NAT) response in triple negative breast cancer (TNBC), one of the most aggressive types of breast cancer (Press release, Personalis, JUN 2, 2025, View Source [SID1234653652]).

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"Many triple negative breast cancer patients receive neoadjuvant therapy prior to surgery as standard of care. The data from these two studies independently suggest that an ultrasensitive ctDNA assay like NeXT Personal could help these patients better understand their risk of relapse, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "We believe this data, once published, can form the basis for seeking reimbursement coverage for neoadjuvant therapy monitoring in breast cancer. We are excited to continue to work with leading collaborators to expand the data around the use of NeXT Personal in breast cancer with the goal of helping breast cancer patients optimize their care."

Results from the PREDICT DNA study were presented yesterday by Dr. Natasha Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial)."

"The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence," said Dr. Ben Park, MD PhD, Vanderbilt-Ingram Cancer Center. "We partnered with Personalis because of their technology’s ultrasensitive detection of ctDNA down to 1 to 3 parts per million. Our results demonstrate that patients who ‘clear’ their ctDNA after upfront chemotherapy have excellent outcomes that mirror those with pCR, identifying a group of patients who, despite having residual disease at the time of surgery, will be at extremely low risk for recurrence. Conversely, those with detectable ctDNA after upfront chemotherapy are at a much higher risk of recurrence, and serial ctDNA measurements after surgery can help identify patients who may benefit from either escalation or de-escalation of therapies. We are truly excited by these results as they will allow us to more precisely risk-stratify patients with breast cancer in future trials and clinical practice."

Key findings included:

ctDNA status after completion of NAT (post-NAT) was highly prognostic for relapse-free survival (RFS).
Patients with ctDNA detected post-NAT were ~10 times more likely to relapse than patients who were ctDNA negative.
Detection of ctDNA post-NAT was more predictive of recurrence than pCR.
Patients who did not have detectable post-NAT ctDNA had excellent outcomes regardless of pathologic response.
Preliminary analyses indicate that patients who had post-surgical ctDNA detected were >85 times more likely to experience disease recurrence.
48% of post-NAT ctDNA detections were <100 PPM, highlighting the importance of NeXT Personal’s ultrasensitive performance.
Overall, the results suggest that ultrasensitive ctDNA detection in patients with TNBC after completion of NAT and prior to surgery may be used as a prognostic marker, independent of pCR, to guide clinical decision making for additional adjuvant therapies.
Dr. Luc Cabel, MD, PhD, Institut Curie, Paris, presented results from a second study titled "Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC)." This study included 86 patients with early stage (Stage I-III) TNBC receiving neoadjuvant therapy. Key findings included:

ctDNA was detected in 100% (84/84) of pretreatment baseline plasma samples.
The majority of ctDNA detections during NAT (51%) and post-NAT (55%) were in the ultrasensitive range below 100 PPM of ctDNA.
Post-NAT ctDNA status was highly prognostic. Patients with ctDNA detected post-NAT were ~36 times more likely to have a distant relapse than patients who tested negative.
For patients who were non-pCR, ctDNA negative patients were 93% less likely to relapse than ctDNA positive patients.
ctDNA status can be combined with pCR status to assess patient distant relapse risk following NAT.
Said François-Clément Bidard, MD, PhD, one of the Institut Curie lead investigators on the study, "Our results uncover the clinical need for ultrasensitive MRD testing, and pave the way for ctDNA-based adjuvant therapy decisions in early triple negative breast cancer."

On June 2, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) reported positive results from the Phase III IMforte study of Tecentriq (atezolizumab) in combination with lurbinectedin (Zepzelca) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (Press release, Genentech, JUN 2, 2025, View Source [SID1234653651]). The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Safety was consistent with the known safety profiles of Tecentriq and lurbinectedin. These data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The Lancet.

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"Small cell lung cancer is an aggressive and devastating disease. At the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years," said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. "The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need."

"In the IMforte study, the Tecentriq and lurbinectedin maintenance regimen significantly extended survival for people living with extensive-stage small cell lung cancer," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "This study builds on Tecentriq’s well-established safety and efficacy profile as the first immunotherapy for this cancer type and may provide another approach to help physicians and patients better manage this aggressive disease."

Patients in the IMforte study first completed four cycles of Tecentriq combined with chemotherapy, over the course of approximately three months, before being randomized into maintenance treatment. From the point of randomization, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). No new safety signals were observed.

About the IMforte study

IMforte [NCT05091567] is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq (atezolizumab) plus lurbinectedin versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomized 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS) from randomization into the maintenance phase.

The trial is sponsored by Genentech and co-funded by Jazz Pharmaceuticals.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Important Safety Information and Indications

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:

is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown.
It is not known if Tecentriq is safe and effective when used:

In children for the treatment of SCLC.
What is the most important information about Tecentriq?

Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects.

Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

You may report side effects to the FDA at 1-800-FDA-1088 or View Source

You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.

On June 2, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from a large-scale pan-cancer study of its Signatera Genome assay, which was presented today, June 2nd, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Natera, JUN 2, 2025, View Source [SID1234653650]).

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The study analyzed the performance of Signatera Genome in a cohort of 392 patients (> 2,600 plasma samples) across five different tumor types (breast cancer, non-small cell lung cancer, melanoma, renal cell carcinoma, and colorectal cancer). Key results included:

Excellent pan-cancer performance: Signatera Genome demonstrated overall longitudinal sensitivity of 94% and specificity of 100% across 5 cancer types. Longitudinal sensitivity was 100% in lung cancer and renal cancer, and post-surgical landmark sensitivity was over 70% in both lung cancer and breast cancer.
Ultrasensitive detection: In the surveillance setting, nearly 50% of Signatera-positive cases were detected in the ultra-sensitive range (≤100 parts per million).
Highly predictive of long-term outcomes: In the pancancer cohort, patients who tested Signatera-negative had excellent prognosis, with 100% distant relapse-free survival (DRFS) at 12 months and 99% at 24 months. In contrast, Signatera-positive patients faced a markedly higher risk of recurrence, with DRFS dropping to 41% at 12 months and just 14% at 24 months.
Extended lead times: Signatera Genome detected recurrence 3 months earlier, on average, compared to the Signatera Exome assay.
Demonstrates Signatera’s potential to identify which patients may benefit from adjuvant therapy: Among Signatera-positive patients, those who received adjuvant therapy had significantly improved outcomes, with a 12-month DRFS of 83% compared to 49% for those who did not receive therapy. For Signatera-negative patients, there was no meaningful benefit from adjuvant therapy with a 12-month DRFS of 93% (treated) vs. 98% (observation).
"These results highlight that our ultra-sensitive Signatera Genome assay not only enables detection of ctDNA at extremely low levels, but also provides powerful insights into patient prognosis and treatment response," said Alexey Aleshin, M.D., MBA, corporate chief medical officer and general manager of oncology at Natera. "This is one of the largest MRD studies of a genome tumor-informed MRD assay, and reinforces the excellent performance of Signatera across a wide range of solid tumors."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On June 2, 2025 ASP Isotopes Inc. (NASDAQ: ASPI) and Isotopia Molecular Imaging Ltd. reported to have entered into a strategic agreement to secure the supply of Gadolinium-160 (Gd-160), a critical precursor isotope for producing Terbium-161 (Tb-161), an emerging medical isotope with significant potential in targeted radiotherapeutics (Press release, Isotopia Molecular Imaging, JUN 2, 2025, View Source [SID1234653649]).
This partnership addresses longstanding supply challenges for Gd-160, enabling Isotopia to advance Tb-161-based therapies for prostate cancer, neuroendocrine tumors, and other malignancies.

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Under the agreement, ASP Isotopes will leverage its proprietary Quantum Enrichment technology to provide Isotopia with enriched Gd-160, a stable isotope essential for manufacturing Tb-161.
The collaboration combines ASP Isotopes’ expertise in large-scale isotope enrichment—previously demonstrated through its production of Ytterbium-176 (Yb-176)—with Isotopia’s proven capabilities in commercial-scale medical isotope production. Isotopia has consistently manufactured Lutetium-177 (Lu-177) and maintained weekly Tb-161 production for its clinical trials over the past two years.

Paul Mann, CEO of ASP Isotopes, emphasized the agreement’s significance: "By supplying Gd-160, we are eliminating a major bottleneck in the development of Tb-161 therapies. Our investment in enrichment technology positions us to support the radiopharmaceutical industry’s growing demand for stable isotopes. This partnership accelerates the path to clinical adoption of Tb-161, which could redefine cancer treatment paradigms."

Dr. Eli Shalom, CEO of Isotopia, highlighted Tb-161’s therapeutic advantages: "Tb-161’s dual mechanism of action, including Auger electron emissions, enables precise targeting of micro-metastases while minimizing damage to healthy tissues. This partnership ensures a reliable Gd-160 supply chain, allowing us to scale production and advance our Tb-161-labeled drug candidates toward commercialization. We produce in our site in Israel and shortly the production will start in our second site in Indianapolis in the US."

Tb-161’s Auger electrons induce double-strand DNA breaks in cancer cells, offering potential advantages over Lu-177 and alpha-emitting isotopes. This precision aligns with the oncology field’s shift toward targeted radiotherapeutics, which improve efficacy and reduce side effects. The agreement comes as global interest in radiopharmaceuticals surges, driven by their ability to deliver localized radiation therapy via tumor-seeking molecules.