On September 13, 2026 GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co., Ltd., reported positive overall survival (OS) data from ARTEMIS-008, its pivotal phase III trial in China evaluating the B7-H3-targeted antibody-drug conjugate (ADC) risvutatug rezetecan (Ris-Rez) versus topotecan in patients with relapsed small cell lung cancer (SCLC) whose disease progressed following platinum-based first-line therapy. These results, first announced in July, are the first Phase III data to demonstrate an OS benefit for a B7-H3 ADC in any tumour type.

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In the trial, Ris-Rez reduced the risk of death by 54% compared with topotecan, a commonly used treatment option following progression on first-line therapy, meeting the trial’s primary endpoint after a median follow-up of 12.2 months (HR 0.46; 95% CI: 0.35-0.62, p<0.0001). Patients receiving Ris-Rez lived a median of 18.5 months (n=230) compared with 10.3 months for those receiving topotecan (n=231). These results were presented in a Presidential Symposium session at the 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea.

Hesham Abdullah, Senior Vice President, Global Head of Oncology, R&D, GSK said, "These results add to the growing body of evidence for Ris-Rez and mark an important step forward for our lung cancer portfolio. The significant improvement in survival observed in this study, together with an encouraging safety profile, provide further momentum for GSK’s global development of Ris-Rez across later-line and earlier treatment settings for small cell lung cancer."

The OS benefit observed was supported by improvements across key secondary efficacy endpoints. Median progression-free survival as assessed by an independent review committee (IRC) was 7.2 months versus 3.0 months (HR 0.33; 95% CI: 0.25-0.42); IRC-assessed objective response rate was 58.3% versus 12.6%; and IRC-assessed disease control rate was 90.4% versus 60.2% for Ris-Rez and topotecan, respectively.

Patients receiving Ris-Rez experienced fewer severe treatment-related side effects (TRAEs) than those receiving topotecan, with grade 3 or higher TRAEs occurring in 60.9% versus 78.2% of patients, respectively. The most common grade 3 or higher TRAEs with Ris-Rez were decreased neutrophils, decreased white blood cells, anaemia, decreased lymphocytes and decreased platelets. These haematologic TRAEs are considered manageable and consistent with the known side effects in this class of medicines.

Jie Wang, M.D., Chair, Medical Oncology Department, National Cancer Center, Chinese Academy of Medical Sciences and Principal Investigator of the ARTEMIS-008 trial, said, "Relapsed small cell lung cancer remains one of the most challenging cancers to treat, with few therapies delivering meaningful improvements in survival once the disease returns. In ARTEMIS-008, patients receiving Ris-Rez lived substantially longer while experiencing lower rates of severe treatment-related side effects. These findings suggest Ris-Rez could represent an important advance for patients."

GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan, and is advancing a broad global clinical development programme across lung cancer, prostate cancer and other solid tumours, including the phase III EMBOLD SCLC-301 trial in relapsed extensive-stage SCLC, with pivotal data expected next year.

About ARTEMIS-008
ARTEMIS-008 is Hansoh’s multicentre, randomised, open-label, active-controlled phase III trial evaluating Ris-Rez versus topotecan in patients in China with limited- or extensive-stage SCLC whose disease progressed on or after first-line platinum-based therapy. Patients were randomised 1:1 to receive Ris-Rez 8.0 mg/kg every three weeks or topotecan 1.2 mg/m² on days 1–5 of each 21-day cycle. The primary endpoint is statistically significant and clinically meaningful improvement in overall survival. Secondary endpoints include progression-free survival, objective response rate, disease control rate, duration of response and safety.

About risvutatug rezetecan
Ris-Rez is a novel investigational antibody-drug conjugate targeting the B7-H3 protein, which is highly expressed in more than 10 solid tumour types, supporting GSK’s ambition to develop it across more than 40 indications by 2040. More than 1,000 patients have received Ris-Rez as part of GSK’s global EMBOLD clinical trial programme, which includes a phase III trial in late-line extensive-stage small cell lung cancer (ES-SCLC), with additional upcoming phase III trials planned in early-line SCLC and metastatic prostate cancers. Ris-Rez has received several global regulatory designations to date, such as orphan drug designations in the US, Japan and the EU for SCLC, and Breakthrough Therapy Designation in the US and Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC, among others.1,2,3,4,5

About small cell lung cancer
Small cell lung cancer (SCLC) is associated with rapid progression and accounts for approximately 10-15% of all lung cancer diagnoses worldwide.6 SCLC is characterised by early metastatic spread, frequent relapse and poor prognosis.6 Approximately 70% of patients with SCLC are diagnosed with extensive-stage disease (ES-SCLC), meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.6,7 Median overall survival for patients with ES-SCLC treated with current standard-of-care therapies is approximately 12 to 13 months.7 Despite advances in treatment, outcomes for patients with ES-SCLC remain poor and risk of disease progression or recurrence remains high, underscoring the need for new therapies that can improve outcomes for patients facing this aggressive cancer.

(Press release, GlaxoSmithKline, SEP 13, 2026, View Source [SID1234670773])

On September 12, 2026 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported an abstract for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) taking place September 12 – 15 in Seoul, South Korea. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb.

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The global Phase 1 data being presented at WCLC 2026 evaluated iza-bren in a randomized expansion cohort across three dose levels in patients with EGFR-mutated metastatic NSCLC who had previously received a third-generation EGFR inhibitor. The randomized dose-expansion results demonstrate promising clinical activity, with higher efficacy observed at the 2.5 mg/kg dose level with a manageable safety profile, and support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose for IZABRIGHT-Lung01, the global registrational study of iza-bren in EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor. The data further demonstrated the consistent efficacy and safety profile in a global population as shown previously in Chinese patients. These findings further advance the global development of iza-bren in EGFR-mutated NSCLC and build upon the clinical activity reported across multiple tumor types at prior international medical meetings.

"The data being presented at WCLC provide important insights into the clinical profile of iza-bren in global patients with previously treated EGFR-mutated metastatic NSCLC," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are encouraged by the promising antitumor activity observed in this randomized dose-expansion cohort, including the increased efficacy observed at the 2.5 mg/kg dose level. Together with the safety and pharmacokinetic findings, these results support 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose and represent an important step forward as we advance the global registrational study, IZABRIGHT-Lung01, in patients with EGFR-mutated NSCLC following progression on a third-generation EGFR inhibitor."

Details of the presentations at WCLC are below:‍‍

Phase 1 Global Study of Iza-bren in Patients with Metastatic EGFR-mutated NSCLC: Results of the Randomized Dose Expansion Cohort
Session Title: OA10 – Novel Antibodies and ADCs – Are They HERalding New Benchmarks?
Presentation: OA10.01
Speaker: Alexander Spira (United States)
Session Date & Time: Monday Sep 14, 2026 12:00 PM – 1:15 PM (KST)

About iza-bren
Iza-bren (BL-B01D1) is a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released, causing cytotoxic stress that leads to cancer cell death. Iza-bren is being developed under a license and collaboration agreement by and between SystImmune and Bristol Myers Squibb.

(Press release, SystImmune, SEP 12, 2026, View Source [SID1234670759])

On September 11, 2026 Astrazeneca reported that the SERENA-4 Phase III trial of Etcamah (camizestrant) in combination with palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, did not meet the primary endpoint of progression-free survival (PFS), however a numerical improvement was observed in the upfront 1st-line treatment of patients with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer who have not received any systemic treatment for advanced disease. The trial evaluated the Etcamah combination versus treatment with an aromatase inhibitor (anastrozole) in combination with palbociclib.

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Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Whilst we are disappointed by the SERENA-4 outcome, it sharpens our focus on maximising the number of patients who can benefit from Etcamah today based on SERENA-6 and reinforces the importance of ESR1 testing for patients on first-line therapy. Early breast cancer represents an important opportunity, and we remain confident in the long-term potential of Etcamah in the early setting as we advance our broader programme."

The safety profile of Etcamah in combination with palbociclib in SERENA-4 was consistent with the known safety profile of each medicine, with no new safety concerns identified. Data will be shared in due course.

Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) is approved in the US, EU, Japan and several other countries for the treatment of adult patients with hormone receptor (HR)-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer upon detection or emergence of ESR1 mutation during 1st-line endocrine-based therapy, based on the results from the SERENA-6 Phase III trial.

Etcamah is currently being evaluated in the most comprehensive oral SERD development programme in early breast cancer. Encompassing approximately 10,000 patients, the CAMBRIA-1 and CAMBRIA-2 Phase III trials are designed for patients at both intermediate and high risk of recurrence in the adjuvant setting, evaluating Etcamah as a monotherapy, in combination with CDK4/6 inhibitors and following CDK4/6 inhibitor treatment to address areas of unmet need in HR-positive, HER2-negative breast cancer.

Notes

ER-positive breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million patients were diagnosed with breast cancer in 2024, with more than 690,000 deaths globally.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2

HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.2 ERs often drive the growth of HR-positive breast cancer cells.3 More than 97% of HR-positive breast cancer tumours are ER-positive.4,5

SERENA-4
SERENA-4 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with palbociclib, a CDK4/6 inhibitor, versus treatment with an aromatase inhibitor (AI) (anastrozole) in combination with palbociclib in patients with ER-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease).

The global trial enrolled 1,371 adult patients, newly diagnosed with Stage IV de novo or recurrent disease who had not received any systemic treatment for metastatic disease. Patients with recurrence from early-stage disease had received at least 24 months of standard adjuvant endocrine therapy (AI or tamoxifen), and at least 12 months had elapsed since the last dose of adjuvant AI therapy without disease progression on treatment.

The primary endpoint of the SERENA-4 trial is PFS as assessed by investigator, with secondary endpoints including OS, PFS2, and health-related quality of life (HRQOL).

Etcamah
Etcamah is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally, once daily. The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is 75mg.

Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer upon detection or emergence of ESR1 mutation during 1st-line endocrine-based therapy, based on the results from the SERENA-6 Phase III trial.

The broad, robust and innovative Etcamah clinical development programme, including the CAMBRIA-1 and CAMBRIA-2 Phase III trials, is evaluating the safety and efficacy of Etcamah when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer.

(Press release, AstraZeneca, SEP 11, 2026, View Source [SID1234670777])

On September 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) (the "Company"), a clinical-stage biotechnology company pioneering the development of advanced in vivo CAR-T therapies for cancer and autoimmune disease, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 3,105,591 shares of common stock (or pre-funded warrant in lieu thereof), series C warrants to purchase up to 3,105,591 shares of common stock and series D warrants to purchase up to 3,105,591 shares of common stock, at a combined purchase price of $0.805 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement. The series C warrants and the series D warrants will have an exercise price of $0.805 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants (the "Stockholder Approval Date"). The series C warrants will expire six years from the later of the Stockholder Approval Date and the Effectiveness Date (as defined below) and the series D warrants will expire three years from the later of the Stockholder Approval Date and the Effectiveness Date. The private placement is expected to close on or about September 14, 2026, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering are expected to be approximately $2.5 million, prior to deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series C warrants and the series D warrants, if fully exercised on a cash basis, will be approximately $5 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above are being offered in a private placement exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) thereof and/or Regulation D promulgated thereunder and, along with the shares of common stock 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 shares of common stock 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, the Company has agreed to file a registration statement covering the resale of the common stock (or the shares of common stock issuable upon exercise of the pre-funded warrant in lieu thereof) issued in the private placement and the shares of common stock issuable upon exercise of the warrants issued in the private placement (the date of effectiveness of such 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, Tempest Therapeutics, SEP 11, 2026, View Source [SID1234670764])

On September 11, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported that updated data on the Company’s [212Pb]VMT-α-NET program have been accepted for presentation as detailed below at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2026 on Molecular Targets and Cancer Therapeutics taking place November 18 to 20, 2026 in Barcelona, Spain. The conference plans to release further details for abstracts on November 4, 2026.

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Presenter Abstract Title Presentation Details
Vikas Prasad, Washington University School of Medicine Cohort level safety and efficacy results for [212Pb]VMT-α-NET in advanced somatostatin receptor subtype 2 (SSTR2+)-expressing neuroendocrine tumors (NETs): Cohorts 1–3 Abstract Number: 334
Session Type: Poster session
Session Title: New drugs
Session Date: November 20, 2026
Session Time: 9:00am – 3:00pm CET / 3:00am – 9:00 am EST
About [²¹²Pb]VMT-α-NET

Perspective designed [212Pb]VMT-α-NET to target somatostatin receptor subtype 2 (SSTR2), and to deliver the alpha-emitting radioisotope lead-212, or ²¹²Pb, to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation and dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive tumors who have not received prior radiopharmaceutical therapies (RPT).

Interim clinical data from the study, with a data cut-off date of April 17, 2026, were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026. These data included efficacy results for half of the patients in Cohort 2 and both patients in Cohort 1. Initial efficacy data for the remaining patients in Cohort 2 and patients in Cohorts 3 and 4 are pending. The Company plans to submit additional data for presentation at future medical conferences in 2026 and 2027.

(Press release, Perspective Therapeutics, SEP 11, 2026, View Source [SID1234670763])