On August 20, 2025 Agilent Technologies Inc. (NYSE: A) reported that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer (Press release, Agilent, AUG 20, 2025, View Source [SID1234655417]). This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

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The mismatch repair (MMR) pathway corrects DNA replication errors to maintain genomic stability1. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency, leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition2.

MMR IHC Panel pharmDx (Dako Omnis) is an immunohistochemical (IHC) panel specifically developed and validated to detect the loss of function of any of the four MMR proteins in formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue. Agilent’s panel is the only FDA-approved companion diagnostic IHC panel to diagnose colorectal cancer patients eligible for treatment with Opdivo alone or in combination with Yervoy.

"This approval marks an important step forward in the ongoing effort to improve colorectal cancer care," stated Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. "Our new CDx product offers healthcare providers an additional tool to identify mismatch repair deficiency in patients, complementing existing options and enhancing the ability to tailor immunotherapy treatments. By providing more choices, we aim to support better tumor control and potentially improve progression-free survival, ultimately contributing to patient care and well-being."

Agilent partnered with Bristol Myers Squibb to develop the MMR IHC Panel pharmDx (Dako Omnis). This highlights the collaborative efforts between Agilent and Bristol Myers Squibb in developing and gaining approval for diagnostic assays that aid in selecting patients for specific treatments.

Opdivo and Yervoy are registered trademarks of Bristol-Myers Squibb Company.

On August 20, 2025 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that its management team will participate in the following upcoming investor conferences in September (Press release, Arcus Biosciences, AUG 20, 2025, View Source [SID1234655416]):

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Citi’s 2025 Biotech Back to School Conference
Date: Wednesday, September 3rd, 2025
Location: Boston, MA
Format: Fireside chat & 1×1 meetings
Time: 11:15 a.m. ET

H.C. Wainwright 27th Annual Global Investment Conference
Date: Tuesday, September 9th, 2025
Location: New York, NY
Format: Fireside chat & 1×1 meetings
Time: 8:00 a.m. ET

Morgan Stanley 23rd Annual Global Healthcare Conference
Date: Wednesday, September 10th, 2025
Location: New York, NY
Format: Fireside chat & 1×1 meetings
Time: 8:30 a.m. ET

Live webcasts of the fireside chats will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. Replays will be available following the live event.

On August 20, 2025 Novocure (NASDAQ: NVCR) reported it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer (Press release, NovoCure, AUG 20, 2025, View Source [SID1234655415]).

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This submission is supported by the PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median overall survival for patients treated with TTFields and GnP compared to GnP alone. The PANOVA-3 data was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where the presentation was selected for inclusion in the "Best of ASCO (Free ASCO Whitepaper)" program. The data were simultaneously published in the Journal of Clinical Oncology.

"The submission of our application is a key step in our efforts to advance Tumor Treating Fields therapy as a treatment option for people living with pancreatic cancer," said Ashley Cordova, CEO, Novocure. "This milestone, achieved nine months after the positive topline readout of the PANOVA-3 trial, reflects the focus, drive and commitment of our team to bring this innovative treatment to patients as quickly as possible."

The PMA for pancreatic cancer was submitted as a PMA Panel-Track Supplement to Optune Lua, which is currently indicated for the treatment of patients with non-small cell lung cancer (NSCLC). The PMA supplement is expected to be converted to a separate, original PMA for the treatment of pancreatic cancer.

Novocure anticipates an approval decision in the second half of 2026.

About PANOVA-3

PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

Quality of life outcomes further reinforced the clinical benefit of TTFields therapy, with patients treated with TTFields therapy exhibiting a statistically significant extension in pain-free survival (secondary endpoint) and a significant preservation of quality of life in terms of global health status, pain, pancreatic pain, and digestive symptom domains.

TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On August 20, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that Shaun Bagai, Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Renovorx, AUG 20, 2025, View Source [SID1234655414]). The conference will be held at the Lotte New York Palace Hotel in New York City, September 8-10, 2025.

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Mr. Bagai will be conducting a virtual presentation, which will be available for the duration of the conference, and afterwards on the Company’s IR website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Mr. Bagai will discuss RenovoRx’s ongoing commercialization efforts and the organic revenue growth reflecting the strong clinical need and market demand for RenovoCath as a standalone targeted drug-delivery product among both new and existing customers.

Mr. Bagai’s presentation will also highlight the latest developments in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial, including the Data Monitoring Committee’s (DMC) recent recommendation to continue the trial following its review of the second pre-planned interim analysis which was triggered by the 52nd death. The TIGeR-PaC trial is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of locally advanced pancreatic cancer (LAPC).

Presentation Details:

Date: Monday, September 8, 2025
Time: 7:00 A.M. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Shaun Bagai, CEO
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact KCSA Strategic Communications at [email protected].

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

On August 20, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the enrollment and dosing of the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody developed by Akeso, in combination with chemotherapy for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma (Press release, Akeso Biopharma, AUG 20, 2025, View Source [SID1234655413]).

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The COMPASSION-33 study represents the third Phase III trial for cadonilimab in gastric cancer. The study aims to improve the radical resection rate in patients with advanced gastric cancer, reduce the risk of recurrence and metastasis, and enhance overall patient outcomes. This study broadens cadonilimab’s clinical application from unresectable advanced gastric cancer to also include resectable advanced gastric cancer, potentially expanding the number of gastric cancer patients that can benefit from its synergistic and simultaneous targeting of PD-1 and CTLA-4 checkpoints.

Cadonilimab, in combination with chemotherapy, has already been approved for the first-line treatment of advanced gastric cancer in China, showing efficacy for patients with tumors across all levels of PD-L1 expression, including those with high, low, and negative PD-L1 expression. Additionally, a Phase III registration trial is currently underway to evaluate the combination of cadonilimab with pulocimab (VEGFR-2) for treating immune therapy (IO)-resistant advanced gastric cancer. This study aims to provide a new, effective second-line treatment option for patients with IO resistance, further demonstrating cadonilimab’s potential to address critical unmet need in this difficult to treat cancer patient populations.

Currently, there are no approved perioperative immunotherapy regimens in the world, highlighting a significant unmet need. Preliminary data suggest that cadonilimab may offer superior efficacy and a more favorable safety profile compared to existing PD-1 therapies for the perioperative treatment of G/GEJ adenocarcinoma. As the world’s first approved and commercially available PD-1/CTLA-4 bispecific antibody, cadonilimab has already demonstrated superior efficacy compared to other treatment options in a Phase III trial for the first-line treatment of advanced G/GEJ adenocarcinoma. Cadonilimab’s ability to meaningfully improve survival outcomes and significantly reducing risk of death for patients across all levels of PD-1 expression is particularly meaningful. Whereas current approved PD-1 treatments have demonstrated very limited or no survival benefit for patients with G/GEJ tumors that have low or negative PD-L1 expression, cadonilimab has demonstrated clinically meaningful survival benefit even in this difficult to treat patient population. Moreover, in patients with higher levels of PD-L1 expression, cadonilimab has demonstrated superior overall survival benefits compared to other approved PD-1 treatments in the first-line treatment of advanced G/GEJ.