On June 1, 2026 Amgen (NASDAQ:AMGN) reported that the European Commission (EC) has granted marketing authorization for IMDYLLTRA (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.

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The approval was based on results from DeLLphi-304, the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in this setting.1

"Small cell lung cancer is one of the most aggressive solid tumors, with high rates of relapse following first-line treatment and limited treatment options," said Jean-Charles Soria, senior vice president of Oncology at Amgen. "The European Commission’s approval of IMDYLLTRA, the first and only T-cell engager therapy approved to treat small cell lung cancer, marks an important step forward for patients in Europe and reflects our commitment to advancing innovative medicines that can meaningfully improve outcomes for people living with this devastating disease."

DeLLphi-304, the global Phase 3 clinical trial, demonstrated that IMDYLLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001).1

"Patients with small cell lung cancer have historically faced a hard road when they progress after initial treatment, surviving only a few months," said Debra Montague, president, Lung Cancer Europe (LuCE). "Approval of a novel treatment option for people in Europe living with this challenging cancer represents meaningful progress and underscores the urgent need for innovation in lung cancer care."

The safety profile for IMDYLLTRA was consistent with its known profile. The most common adverse reactions were cytokine release syndrome (CRS) (56.7%), decreased appetite (36.4%), pyrexia (31.9%), dysgeusia (31.3%), constipation (30.4%), anaemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatraemia (16.7%), headache (16.3%) and lymphopenia (15.6%). The most common serious adverse reactions were CRS (19.7%) and pyrexia (4.7%).

CRS primarily occurred after the first two doses. As reflected in the Summary of Product Characteristics (SmPC), patients should be monitored from the start of the IMDYLLTRA infusion for 6 to 8 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.2

Amgen’s robust IMDYLLTRA clinical development program includes the DeLLphi clinical trials, which evaluate IMDYLLTRA as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment.

About the Phase 3 DeLLphi-304 Study
DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDYLLTRA as a treatment for patients living with SCLC who progressed on or after one platinum-based chemotherapy regimen. Five hundred and nine patients were randomized to receive either IMDYLLTRA or local standard of care chemotherapy (topotecan in all countries except Japan; lurbinectedin in the U.S., Canada, Australia, Singapore, South Korea; and amrubicin in Japan). The primary outcome measure of the trial is OS. Key secondary outcome measures include progression-free survival (PFS) and patient-reported outcomes (PROs) including disease-related symptoms, physical function, and quality of life.3 Results from DeLLphi-304 were reviewed as a late-breaking presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1,4

About IMDELLTRA/IMDYLLTRA (tarlatamab)
IMDYLLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell. 5,6 DLL3 is a protein that is expressed on the surface of SCLC cells in up to 96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.7,8

About Small Cell Lung Cancer (SCLC)  
SCLC is one of the most aggressive and devastating forms of solid tumor cancer. Each year, SCLC accounts for approximately 13-15% of more than 2.4 million cases of lung cancer diagnosed worldwide.9-11 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.10

About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with SOC therapies in first-line ES-SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone in first-line ES-SCLC in the maintenance setting; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201, a B7-H3 targeting antibody drug conjugate, with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of tarlatamab in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; DeLLphi-312, a randomized Phase 3 study evaluating tarlatamab in combination with carboplatin, etoposide and durvalumab as an induction and maintenance therapy in first-line treatment of ES-SCLC; and DeLLphi-313, a Phase 1b study of tarlatamab in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without a PD-L1 inhibitor in patients with ES-SCLC.12

For more information, please visit www.tarlatamabclinicaltrials.com.

(Press release, Amgen, JUN 1, 2026, View Source [SID1234666296])

On June 1, 2026 ALX Oncology Holdings Inc. ("ALX Oncology" Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that ALX Oncology leadership will participate in a fireside chat presentation at the 2026 Jefferies Global Healthcare Conference in New York.

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The details of the meeting are as follows:

2026 Jefferies Global Healthcare Conference in New York

Format: Fireside Chat Presentation
Date: June 3, 2026
Time: 5:30 PM ET
Webcast link: Available here

The webcast of the 2026 Jefferies Global Healthcare Conference presentation can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. Replay of the webcast will be archived for up to 90 days following the presentation date.

(Press release, ALX Oncology, JUN 1, 2026, View Source [SID1234666295])

On June 1, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported positive overall survival and safety results from a pooled analysis of three prospective Phase I/II clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The results were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Pancreatic cancer remains one of the most lethal of all solid tumors, with a five-year survival rate of less than 10% and survival often measured in only months for patients with advanced disease. Treatment options are particularly limited for patients who are ineligible for chemotherapy or who have progressed through one or more lines of systemic therapy, where historical survival is consistently poor and few effective interventions exist.

The pooled, ad-hoc analysis combined safety and efficacy data from three studies, conducted at the Jewish General Hospital, at the Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel. The analysis included all patients who received the intended Alpha DaRT treatment, with a range of patients having undergone varying lines of prior chemotherapy. Survival was analyzed using the Kaplan-Meier method and assessed by disease stage (locally advanced versus metastatic) and by number of prior chemotherapy lines (zero, one, or two).

Overall Survival Results

Note: Caution should be exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other relevant factors.

Alpha DaRT-treated patients who had received one prior line of chemotherapy achieved a median overall survival of 17.0 months in metastatic disease and 13.8 months in locally advanced disease, from the date of initiation of the prior line of chemotherapy. Alpha DaRT as second-line therapy, measured from study enrollment, achieved an mOS of 11.2 months in metastatic patients, while in the published literature, mOS for metastatic patients with second-line chemotherapy is reported to be ~ 4-6 months (from initiation of second-line chemotherapy), and for the locally advanced patients, achieved an mOS of 11.1 months, vs. ~9 months.

Alpha DaRT-treated patients who had received two prior lines of chemotherapy – a heavily pretreated population for whom there is no established standard of care – achieved a median overall survival of 17.1 months in locally advanced disease and 11.3 months in metastatic disease, from the date of initiation of the second-line chemotherapy. Alpha DaRT as third-line therapy, measured from study enrollment, achieved an mOS of 7.9 months in metastatic patients, and for the locally advanced patients, achieved an mOS of 8.8 months, while in the published literature, mOS for patients with third-line chemotherapy is reported to be ~ 4-7 months (from the initiation of third-line chemotherapy).

Patients who were treated with Alpha DaRT and who had not received any prior chemotherapy demonstrated mOS of 7.1 months from diagnosis in both locally advanced and metastatic diseases, which includes mOS of 6.3 and 5.8 months, from trial enrollment, for locally advanced and metastatic patients, respectively.

Safety Results

Alpha DaRT was observed to have a favorable safety profile. Treatment-associated adverse events were observed in 36% of subjects, and Grade ≥ 3 adverse events were observed in 9% of subjects, including biliary obstruction, abdominal pain, fever, liver enzyme imbalance, and bacteremia. Importantly, there were no treatment-related deaths, all Grade ≥ 3 adverse events resolved, and no chronic adverse events were observed. This safety profile is especially relevant in advanced pancreatic cancer, where patients are often frail and where the cumulative toxicity of ongoing systemic therapy can significantly compromise quality of life.

A key differentiator of Alpha DaRT is its potential as a one-time, minimally invasive intratumoral administration, as compared to continuous oral or intravenous therapy.

Uzi Sofer, CEO of Alpha Tau, stated: "I have always believed deeply in the potential of Alpha DaRT to be highly efficacious, but I say proudly that these results exceeded even my own expectations, and are an outstanding extension of the interim results in these first-in-human trials that we observed last year. To see this level of survival, achieved with a one-time treatment and without chronic side effects, in patients who today have so little to turn to, strengthens our resolve to bring Alpha DaRT to as many of these patients as possible, as quickly as we responsibly can. These first-in-human results are fantastic, and they demonstrate the potential of Alpha DaRT as a monotherapy, even when compared to standard-of-care chemotherapies. And now we are even more excited about the treatment design of our U.S. IMPACT trial. In treating pancreatic cancer, our goal is not to replace chemotherapy or other next-generation systemic therapies, our goal is to explore whether Alpha DaRT can serve as a compelling focused local therapy and add a concurrent therapeutic boost without exacerbating the harsh systemic side effects of standard chemotherapy regimens. We are excited about the advent of new systemic therapy options for pancreatic cancer patients, and given the safety profile observed thus far for Alpha DaRT, we believe there is compelling rationale for exploring further combination trials in the future with new systemic therapies as they become standard-of-care. Pancreatic cancer is one of the cruelest diagnoses, and these patients deserve therapies that deliver not only meaningful efficacy, but also a safety profile and treatment experience that respect their quality of life and fit into their journey rather than dominate it."

Corey Miller, MD, MSc, Director of Therapeutic Endoscopy of the Division of Gastroenterology at the Jewish General Hospital, Assistant Professor of Medicine at McGill University, and Principal Investigator in Canada, commented: "As the first physician in the world to deliver Alpha DaRT into the pancreas using an endoscopic ultrasound-guided approach, seeing these results is genuinely extraordinary for me. I treated some of the very first patients in this program, and that trajectory, from the early procedures all the way through to receiving the survival outcome data with no observed chronic toxicity, has been truly fantastic to witness and a privilege to be a part of."

Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "These pooled survival and safety data provide extremely encouraging reinforcement of our clinical strategy which we are moving decisively to execute across a broad and increasingly global clinical program. Historically, local therapy has not played a big role in treating non-resectable pancreatic cancer due to poor clinical trial results secondary to limitations on dose escalation in the pancreas in light of the sensitive organs in the area, as well as the inability to dose chemotherapy at systemic therapy levels concurrently with local therapy. We seek to make local therapy an integral part of the treatment of pancreatic cancer, without compromising the ability to deliver systemic therapy concurrently. Our flagship multicenter IMPACT trial in the United States continues to advance, evaluating Alpha DaRT in combination with chemotherapy in patients with newly diagnosed unresectable pancreatic cancer. The ACAPELLA trial in France, evaluating Alpha DaRT alongside capecitabine in patients with locally advanced pancreatic cancer, is underway following the treatment of its first patient. And our work at the prestigious University of Verona’s Pancreas Institute is extending the program to include a percutaneous delivery approach, broadening the range of patients who may be able to access this therapy. Together, these studies reflect a deliberate, methodical effort to generate the rigorous evidence needed to bring Alpha DaRT to patients with one of the most significant unmet needs in oncology."

About the Studies

The analysis presented is a pooled ad-hoc analysis of three prospective Phase I/II clinical studies conducted at centers in Canada and Israel, evaluating EUS-guided intratumoral Alpha DaRT in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma across varying lines of prior chemotherapy. The analysis included all cases that received the intended treatment. Survival analyses used the Kaplan-Meier method, measured from the time of enrollment or from the initiation of the previous line of chemotherapy, to death, and were analyzed by disease stage and number of prior chemotherapy lines (zero, one, or two).

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, JUN 1, 2026, View Source [SID1234666294])

On June 1, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company’s original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study) (see: ClinicalTrials.gov NCT05927142).

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The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study’s primary endpoint, Clinical Benefit Rate ("CBR"), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers.

AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks.

"This achievement represents another important execution milestone for the DURIPANC program and further strengthens the momentum behind Ampligen in pancreatic cancer," said AIM Chief Executive Officer Thomas K. Equels. "We continue to observe encouraging survival outcomes, consistently high quality-of-life measures and Ampligen’s strong safety profile. Together with our ongoing Phase 3 planning efforts, orphan drug designations in the United States and Europe, expanding global intellectual property portfolio, and growing body of positive clinical data, we believe Ampligen is advancing toward a significant value-inflection period for AIM and, most importantly, toward addressing a critical unmet need for pancreatic cancer patients."

Mr. Equels continued, "We remain on track to complete Ampligen dosing for all subjects in August, which should allow us to evaluate the study’s critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy."

The enrollment milestone further advances AIM’s broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company’s strategy of advancing Ampligen toward pivotal-stage development.

DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life.

Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.

(Press release, AIM ImmunoTech, JUN 1, 2026, View Source [SID1234666293])

On June 1, 2026 Imugene Limited (ASX:IMU), a clinical-stage immunooncology company, reported that azer-cel (azercabtagene zapreleucel) Phase 1b clinical data has been presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois.

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The data was presented by Dr Supriya Gupta, University of Minnesota in the Oral Abstract Session Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia, on 29 May 2026 at 1:00 PM CDT.

ASCO is the world’s leading oncology conference, with more than 40,000 oncology professionals, researchers, and investors attending globally each year. Of more than 8,500 abstracts submitted for consideration at the 2026 Annual Meeting, only a small proportion were selected for oral presentation which is a distinction awarded by ASCO (Free ASCO Whitepaper)’s peer reviewed Scientific Program Committee on the basis of clinical significance and scientific quality. Oral selection places azer-cel among the most significant data readouts of the conference.

As demonstrated by the data presented at ASCO (Free ASCO Whitepaper) on 29 May, 2026; 25 patients in the CAR-T naive cohort with relapsed or refractory blood cancers received azer-cel in combination with low-dose IL-2, and 24 were evaluable for response following their first disease assessment at Day 28. Among these 24 patients, responses were observed across all six cancer subtypes, including:

• DLBCL: 67% response rate
• MZL: 83% response rate
• CLL: 100% response rate
• PCNSL: 50% response rate
• FL: 100% response rate
• WM: 100% response rate

Leslie Chong, Managing Director and CEO of Imugene, said: "The level of interest and depth of questioning from clinicians and researchers at our oral presentation at ASCO (Free ASCO Whitepaper) was genuinely encouraging. These are some of the most rigorous scientific minds in oncology, and the engagement we saw reflects growing recognition of azer-cel and its potential to offer patients further treatment options. We look forward to providing further updates as the data matures."

The ASCO (Free ASCO Whitepaper) Presentation is available at imugene.com/investors/conferencepresentations.

The Phase 1b azer-cel clinical trial is a multi-cohort study evaluating patients with relapsed or refractory CD19-positive B-cell malignancies (blood cancers), including both CAR-T naïve and CAR-T relapsed/refractory cohorts. The study has recently expanded into Cohort 3, which evaluates azer-cel in concurrent dosing with Bruton Tyrosine Kinase inhibitors (BTKi). The first patient in this cohort was dosed on 28 May 2026.

The trial is active across ten US sites and five Australian sites.

(Press release, Imugene, JUN 1, 2026, View Source [SID1234666259])