On June 22, 2026 RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the closing of its previously announced private placement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten thousand (10,000) ordinary shares of the Company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of $0.70 per ADS (or ADS equivalent in lieu thereof) and accompanying warrants. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date (as defined below), and the Series A-2 warrants have an exercise price of $0.70 per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date.

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The upfront proceeds are expected to strengthen RedHill’s near-term liquidity and support a strategic, transformative, potential acquisition of commercial-stage, revenue-generating pharmaceutical product assets, which, if completed, would significantly expand the Company’s commercial portfolio and revenue base. No definitive acquisition agreement has been executed, and the potential transaction remains subject to various conditions. There can be no assurance that any such transaction will be completed.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering were approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the ordinary shares of the Company represented by ADSs underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities issued in the private placement and ordinary shares of the Company represented by ADSs underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, RedHill Biopharma, JUN 22, 2026, View Source [SID1234668879])

On June 22, 2026 USWM CT, LLC (US WorldMeds) reported that the U.S. Food and Drug Administration (FDA) has granted full approval of TECELRA (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Administered as a single infusion, TECELRA became the first engineered T-cell therapy for a solid tumor cancer to receive accelerated FDA approval in the United States, granted in August 2024.

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"Today’s approval marks an important milestone not only for US WorldMeds, but for the synovial sarcoma community," said Breck Jones Sr., Founder and CEO of US WorldMeds. "With the transition to full approval, TECELRA continues to represent an important treatment option for appropriate patients with biomarker-eligible, advanced synovial sarcoma. This approval is supported by additional clinical evidence which may provide physicians, patients, and families with confidence as they consider treatment decisions. The expansion to include patients as young as 12 years old further broadens access to this personalized approach."

"What sets TECELRA apart is that it is personalized to each individual, engineering a patient’s own T-cells to detect, target, and attack their cancer. Until today, that option was only available to adults," said Kristen Gullo, Senior Vice President of US WorldMeds. "For patients 12 years of age and older with biomarker-eligible, advanced synovial sarcoma, today’s decision opens the door to a new treatment approach that was previously out of reach and offers hope where options have been extremely limited."

The full FDA approval and expanded indication for TECELRA was based on results of the SPEARHEAD-1 study (Cohorts 1, 2 and 3), an open-label, single-arm clinical study, which included 137 patients. The primary efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of 43.8% with a complete response rate of 3.6%. The median duration of response was 5.3 months (95% CI: 4.5, 8.2). Among patients who were responsive to the treatment, 31.9% had a duration of response of 24 months or longer.*

"For children as young as 12 with advanced synovial sarcoma, treatment options have been limited and navigating care decisions can be challenging," said Amy Armstrong, MD, Associate Professor of Pediatrics at Washington University School of Medicine in St. Louis and Director of the Solid Tumor Program at Siteman Kids at St. Louis Children’s Hospital. "The availability of an engineered cell therapy for adolescents introduces an important new option for patients who are biomarker-eligible, allowing us to incorporate this approach into treatment planning based on the same evidence that has guided adult care. This is a meaningful step forward for the field."

For more information about TECELRA visit www.TECELRA.com.

About Synovial Sarcoma
There are more than 50 different types of soft tissue sarcomas which can arise in fat, muscle, nerves, fibrous tissues, blood vessels, or deep skin tissues.1 Synovial sarcoma accounts for approximately 5 to 10% of all soft tissue sarcomas (there are approximately 13,400 new soft tissue sarcoma cases in the U.S. each year).1,2 Approximately one-third of patients with synovial sarcoma are diagnosed under the age of 30.2 The five-year survival rate for people with metastatic disease is approximately 20% and recurrence is common in advanced disease.1,3

About TECELRA
TECELRA (afamitresgene autoleucel) is a genetically modified autologous T cell immunotherapy indicated for adult and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is made from a patient’s own white blood cells that are genetically modified to recognize and attack cancer cells. A healthcare provider will perform tests to see if TECELRA is right for each patient.

IMPORTANT SAFETY INFORMATION
Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, fatigue, infection, fever (100.4°F/38°C or higher), constipation, vomiting, headache, diarrhea, fast heart rate, cough, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, decreased red blood cell count, and decreased platelet count.

You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

(Press release, US WorldMeds, JUN 22, 2026, View Source [SID1234668876])

On June 22, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") reported that translational research results on its sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) in combination with osimertinib as first-line treatment for advanced epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) have been published online in Cancer Cell, an international academic journal.

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The paper, titled "Targeting TROP2 in drug-tolerant persister cells delays EGFR tyrosine kinase inhibitor resistance in non-small-cell lung cancer," was led by Professor Li Zhang and Professor Wenfeng Fang from the Sun Yat-sen University Cancer Center. The study shows that trophoblast cell-surface antigen 2 (TROP2) expression is upregulated in residual drug-tolerant persister (DTP) cells after EGFR tyrosine kinase inhibitor (TKI) treatment; in preclinical models, sac-TMT combined with osimertinib inhibited DTP cell formation and delayed tumor recurrence. These findings provide translational medicine evidence for the combination of TROP2-directed antibody drug conjugate (ADC) and EGFR‑TKI in delaying drug resistance, and further underscore the differentiated value of sac-TMT as a key combination partner for EGFR-TKIs.

Building on the above research and clinical development plans, the Company is advancing a Phase III registrational study (NCT06670196) of sac-TMT in combination with osimertinib versus osimertinib monotherapy as first-line treatment for locally advanced or metastatic EGFR-mutant non-squamous NSCLC. The study is designed to evaluate the efficacy and safety of sac-TMT (4 mg/kg, Q2W) plus osimertinib compared with osimertinib monotherapy in this indication. Patient enrollment in China has been completed, and the study is currently in the follow-up and data maturity phase.

In addition, the Company is advancing clinical exploration of sac-TMT for earlier-stage EGFR-mutant NSCLC. A Phase II study (NCT07329322) is ongoing to evaluate sac-TMT in combination with osimertinib or as monotherapy in the neoadjuvant setting for EGFR-mutant resectable NSCLC, further exploring the potential value of sac-TMT in perioperative treatment.

This publication in Cancer Cell reinforces the scientific foundation for combining sac-TMT with EGFR-TKIs as first-line treatment for EGFR-mutant NSCLC. The Company will continue to explore the potential of this combination regimen in earlier-line treatment, resistance delay, and long-term benefit, building on the approved indications and clinical development plan of sac-TMT in EGFR-mutant NSCLC. Kelun-Biotech remains committed to driving innovation in treatment paradigms for EGFR-mutant NSCLC and expanding therapeutic options for patients.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have programmed death ligand 1 (PD-L1) tumor proportion score (TPS)≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JUN 22, 2026, View Source [SID1234668873])

On June 22, 2026 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that as informed by the National Medical Products Administration ("NMPA"), the New Drug Application ("NDA") of satricabtagene autoleucel ("satri-cel"), the proprietary autologous humanized Claudin18.2 CAR T-cell therapy product, was approved for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. Satri-cel is the world’s first approved CAR T-cell therapy product for the treatment of solid tumors.

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Gastric cancer is one of the malignancies with the highest disease burden worldwide, ranking fifth in both incidence and mortality globally, with approximately 970,000 new cases and 660,000 deaths annually[1]. More than 70% of new and fatal cases occur in Asia[2], and Chinese patients account for approximately 47% of the global gastric cancer burden[3]. According to statistics from the National Cancer Center of China, there were approximately 360,000 new cases and 260,000 deaths from gastric cancer in China in 2022, ranking fifth in cancer incidence and third in cancer-related mortality[4]. Despite continuous advances in surgical techniques and comprehensive treatment modalities, gastric cancer is insidious in onset. In China, the proportion of early-stage gastric cancer diagnosis remains below 20%, and the 5-year survival rate for advanced gastric cancer is only about 10%[5]. Gastric cancer is characterized by high incidence, low early diagnosis rate, high heterogeneity, and high mortality. Conventional chemotherapy drugs have reached a plateau, targeted therapy options are limited, and the proportion and magnitude of benefit from immunotherapy still urgently need to be improved. Therefore, patients with unresectable or metastatic gastric cancer still face substantial unmet medical needs, and there is an urgent demand to drive the discovery and exploration of more precision therapies and novel anti-tumor agents.

Claudin18.2 is a highly selective marker protein. Its expression in normal healthy tissues is very limited, occurring only in differentiated gastric mucosal epithelial cells, whereas it is highly expressed in gastric cancer and other malignant tumors. Satri-cel is an autologous CAR-T cell product targeting Claudin18.2. It is genetically modified to express a CAR construct consisting of a humanized Claudin18.2-specific single-chain monoclonal antibody fragment (hu8E5-2I), a CD8α hinge region, a CD28 transmembrane region, a CD28 intracellular signaling domain (CD28 ICD), and a CD3ζ intracellular signaling region. To our knowledge, we were the first in the world to successfully identify, validate, and report the solid tumor-associated antigen Claudin18.2 as a valid target for CAR T-cell therapy. To further address the challenges of the tumor microenvironment in treating solid tumors, the company independently developed an innovative, patent-protected preconditioning regimen which is to be administered prior to infusion of satri-cel. This regimen features the addition of low-dose nab-paclitaxel to the conventional lymphodepletion regimen comprising cyclophosphamide and fludarabine to enhance the infiltration and anti-tumor efficacy of CAR T cells. The Company has implemented global patent layout around satri-cel, covering the target, indications, dosage, and preconditioning regimens, among others.

The clinical efficacy of satri-cel has received authoritative recognition from top international medical journals. The results of its confirmatory randomized controlled study have been published in The Lancet [6]. Clinical data show that among patients with advanced, heavily pretreated G/GEJ cancer who have extremely limited treatment options and a very poor prognosis, satri-cel demonstrated significant efficacy benefit and a good safety profile compared to existing treatments, bringing a new treatment option to patients with advanced gastric cancer. This major breakthrough not only establishes a new standard for CAR-T therapy in solid tumors but also lays a solid scientific foundation for advancing to earlier lines of therapy, exploring combination treatment regimens, and expanding applications to other Claudin18.2-positive solid tumors such as pancreatic cancer and biliary tract cancer.

Professor Lin Shen’s team at Peking University Cancer Hospital led the clinical studies of satri-cel. Professor Shen commented, "For patients with advanced G/GEJA who have failed multiple lines of prior therapy, previous treatment options were extremely limited and the prognosis was very poor. The approval of satri-cel provides us with a novel and effective therapeutic weapon. This product has brought clinically meaningful and significant benefits to such patients, with remarkable efficacy that is difficult to achieve with existing treatment modalities. More importantly, as a CAR-T product, satri-cel offers patients the opportunity to break free from the constraints of frequent hospital visits for treatment, achieving a leap from ‘prolonging survival’ to ‘improving quality of life.’ As the world’s first successfully marketed CAR-T therapy for solid tumors, satri-cel not only fills the gap in later-line treatment for advanced gastric cancer but also ushers in a new era of cellular therapy for solid tumors. This breakthrough lays a critical foundation for advancing frontline therapy and combination treatment strategies, and is expected to reshape the treatment landscape of gastric cancer and even gastrointestinal tumors. We believe that with the promotion of clinical application, this innovative therapy will illuminate new hope for life for the vast number of gastric cancer patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, stated, "The approval and launch of satri-cel is an important milestone event marking the advancement of CAR-T cell therapy from hematologic malignancies to solid tumors. This would not have been possible without the trust and support of the patients and their families who participated in the clinical trials, the investigator teams, partners, regulatory agencies, and relevant departments. We will go all out to advance the clinical application and market access of satri-cel, ensuring that this innovative therapy benefits Chinese patients widely and in a timely manner. At the same time, we will strive to expand this product to more countries and regions to meet greater medical needs. In addition, we are also exploring first-line sequential therapy and postoperative adjuvant therapy for advanced gastric cancer, with the aim of helping more patients achieve deeper therapeutic benefits and even the possibility of cure."

About Satri-cel

Satri-cel is an autologous CAR T-cell therapy product against the protein Claudin18.2 that is the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in June, 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy, making it the world’s first approved CAR T-cell therapy product for solid tumors.

The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase I clinical trial for pancreatic cancer adjuvant therapy in China (NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (NCT07179484).

(Press release, Carsgen Therapeutics, JUN 22, 2026, View Source [SID1234668872])

On June 22, 2026 Laboratoires Pierre Fabre reported that the European Commission (EC) has approved BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The approval is based on the results from the Phase 3 BREAKWATER trial, which assessed the efficacy and safety of BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

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Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: "We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant mCRC. Today’s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited."

In the Phase 3 BREAKWATER trial, the regimen of BRAFTOVI in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with oxaliplatin-based chemotherapy with or without bevacizumab (median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40–4.25; P<0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4) compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.

(Press release, Pierre Fabre, JUN 22, 2026, View Source [SID1234668871])