On October 18, 2026 GSK plc (LSE/NYSE: GSK) reported the first global data for risvutatug rezetecan (Ris-Rez), its investigational B7-H3-targeted antibody-drug conjugate (ADC), in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). Results from the phase Ib dose-optimisation portion of the EMBOLD PanTumour-101 trial showed positive anti-tumour activity and a manageable safety profile, adding to recently reported positive phase III data in patients with SCLC in China.1

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In the trial, Ris-Rez achieved a confirmed objective response rate (ORR) of 61% among evaluable patients at the 8 mg/kg dose (n=11/18; 95% CI: 35.7-82.7), compared with 32% at the 6 mg/kg dose (n=7/22; 95% CI: 13.9-54.9). These findings will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain. Along with data from Hansoh’s phase III ARTEMIS-008 study in SCLC, this data supported selection of the 8 mg/kg dose currently being evaluated in GSK’s global phase III EMBOLD SCLC-301 study.

Hesham Abdullah, Senior Vice President, Global Head of Oncology, R&D, GSK said, "Today’s first global data for Ris-Rez build on the statistically significant overall survival benefit recently reported in Hansoh’s pivotal Chinese trial. As the data for Ris-Rez continues to grow, we remain focused on accelerating development in extensive-stage small cell lung cancer, where patients often relapse quickly and urgently need more treatment options."

The safety profile was manageable across both dose levels at a median follow-up of 100.5 days. Grade 3 or higher treatment-related adverse events (TRAEs) were observed in 42% of patients receiving 8 mg/kg and 15% of those receiving 6 mg/kg, with haematological events being the most common. The overall rate of interstitial lung disease (ILD) was low (2%; 1 out of 50 patients) and the case was moderate (grade 2).

Hye Ryun Kim, MD, PhD, Division of Medical Oncology, Yonsei Cancer Center, and a study investigator in the EMBOLD PanTumour-101 study, said, "Extensive-stage small cell lung cancer remains one of the most aggressive cancers we treat, with five-year survival rates typically in the single digits. Patients whose disease relapses often have limited options, and current therapies can be difficult to tolerate. The response rates and manageable safety profile observed with Riz-Rez are encouraging and support its ongoing development in this setting."

These data will be presented alongside a broader set of findings from the EMBOLD programme at ESMO (Free ESMO Whitepaper) 2026, including global dose-escalation results from EMBOLD PanTumour-101, an analysis of ILD across the Ris-Rez early clinical programme, and the design of the global phase III EMBOLD SCLC-301 study. Real-world evidence from the RESONANCE study further demonstrates the complexity of treatment decision-making after relapse in ES-SCLC and highlights the absence of a clear treatment standard in later lines of therapy. Together, these findings contribute to the growing body of evidence for Ris-Rez and reflect GSK’s focus on advancing targeted medicines where significant patient need and scientific opportunity remain.

About EMBOLD PanTumour-101
EMBOLD PanTumour-101 (NCT06551142) is a global, open-label phase Ia/b study evaluating the safety, tolerability and clinical activity of Ris-Rez monotherapy in adult patients with advanced or metastatic solid tumours. In the phase Ib dose-optimisation portion of the study, patients with relapsed (2L+) extensive-stage small cell lung cancer were randomised to receive Ris-Rez 6 mg/kg or 8 mg/kg intravenously every three weeks until disease progression, unacceptable toxicity, loss to follow-up or death. The analysis presented at ESMO (Free ESMO Whitepaper) 2026 included 50 patients who had received a median of two prior therapies. The study population included patients with prior topoisomerase-1 inhibitor or tarlatamab exposure, as well as patients with brain or liver metastases. Enrolment in the phase Ib dose-optimisation portion of the trial was still ongoing at data cut-off, and longer follow-up will be needed to further characterise the durability of response.

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. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez. More than 1,000 patients have received Ris-Rez as part of GSK’s global EMBOLD clinical trial programme, which includes phase III trials in late-line extensive-stage small cell lung cancer (ES-SCLC) and metastatic castration-resistant prostate cancer (mCRPC), with additional upcoming phase III trials planned in early-line SCLC and chemo-naïve mCRPC. Ris-Rez has received several global regulatory designations to date, including 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.2,3,4,5,6

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.7 SCLC is characterised by early metastatic spread, frequent relapse and poor prognosis.7 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.7,8 Median overall survival for patients with ES-SCLC treated with current standard-of-care therapies is approximately 12 to 13 months.8 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, OCT 18, 2026, View Source [SID1234673539])

On October 16, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that three studies of orelabrutinib, its novel BTK inhibitor, have been selected for oral presentations at the 88th Annual Meeting of the Japanese Society of Hematology (JSH 2026).

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The studies focused on real-world data of orelabrutinib monotherapy for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL), preliminary Phase II results of an orelabrutinib regimen as first-line treatment for marginal zone lymphoma (MZL), as well as Phase II results of an orelabrutinib regimen as first-line treatment for diffuse large B cell lymphoma (DLBCL). Professor Huayuan Zhu from Jiangsu Provincial Hospital, and professor Wenyu Shi from Affiliated Hospital of Nantong Hospital, delivered the oral presentations at the meeting. Key highlights are summarized below:

1. Orelabrutinib Monotherapy in Chinese Patients with CLL/SLL: A Multicenter Real-world Study (Presentation No.: O3-18D-2)

Real-world data support orelabrutinib monotherapy in both first-line and relapsed/refractory (R/R) CLL/SLL.

The retrospective study included 211 patients. At a median follow-up of 33.5 months, median progression free survival (PFS) and median overall survival (OS) were not reached, with 36-month PFS 80.0% and OS 91.3%, demonstrating durable survival benefits of orelabrutinib monotherapy in real-world Chinese patients with CLL/SLL.

The first- and second-line pooled patient group exhibited significantly better PFS than the patients initiated orelabrutinib ≥3rd-line, with 36-month PFS rate of 81.8% vs. 70.3% respectively, suggesting that earlier initiation of orelabrutinib may yield superior progression-free survival benefits.

The study also showed that the safety profile is manageable.

2. Orelabrutinib+Zebetuzumab+Lenalidomide (OZL) in Newly Diagnosed MZL: Phase 2 Preliminary Results (Presentation No.: O3-18D-3)

The chemo-free orelabrutinib+zebetuzumab+lenalidomide regimen demonstrated high response rates with deep remissions and a manageable safety profile in newly diagnosed MZL.

Of evaluable patients, all (100%) achieved overall response (OR) after 6 cycles of induction, including 62.5% complete responses (CRs). Among patients who were Minimal Residual Disease (MRD)-positivity at baseline, 70% achieved MRD negativity at the end of induction.

The safety profile was manageable, with no new safety signals identified.

The study’s primary endpoint is 3-year progression free survival. Recruitment is currently ongoing.

3. PRO Regimen (Polatuzumab, Orelabrutinib, Rituximab) in Frail DLBCL Frontline Setting (Presentation No.: O2-6C-5)

The chemo free orelabrutinib, polatuzumab and rituximab regimen showed high efficacy and manageable safety and is a promising frontline option for elderly and frail DLBCL patients including those over 80 years.

The median age of patients was 78, with 43.6% over 80 and 74.3% with comorbidities. Among patients who completed 6 cycles of efficacy assessment, the complete response (CR) rate was 91.7%, and the overall response rate (ORR) was 95.8%. At a median follow up of 7.0 months, median PFS and OS were not reached and the estimated 9-month PFS rate was 92.8%. Outcomes were similar in patients over 80.

The safety profile is manageable.

The 88th Annual Meeting of the JSH 2026 is hosted by the Japanese Society of Hematology, which was held from Oct. 9-11 at Kyoto, Japan.

More information can be found at JSH official website.

(Press release, InnoCare Pharma, OCT 16, 2026, View Source [SID1234673537])

On October 16, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, reported early clinical improvement in its first patient treated in Abu Dhabi, United Arab Emirates, with investigational intranasal NEO100 through the Company’s Compassionate Care program. According to his treating physicians, the patient, a critically ill three-year-old boy with an aggressive brain tumor, is now breathing independently without ventilator support and beginning to move his legs following initiation of treatment. These early observations involve one patient receiving compassionate-use treatment and do not establish that NEO100 caused the improvement or predict outcomes in other patients.

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"Hearing that this little boy is breathing on his own and beginning to move his legs is profoundly moving. For his family, every sign of progress matters," said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc. "We remain cautious about these early observations and deeply grateful to his physicians and our partner, the Department of Health – Abu Dhabi, for making access to treatment possible."

The treatment reflects coordination between NeOnc, the child’s treating physicians and the Department of Health – Abu Dhabi to provide access to investigational NEO100. The patient did not meet the eligibility criteria for the Company’s NEO100-03 pediatric clinical trial and is receiving treatment outside that trial through NeOnc’s Compassionate Care program. The program provides access to NEO100 for patients with serious or life-threatening conditions who have no comparable or satisfactory treatment alternatives.

"The improvements reported by this child’s treating physicians are encouraging, and continued clinical observation is essential to understand his progress," said Thomas Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. "This individual experience does not establish safety or efficacy. Our pediatric clinical program is designed to evaluate NEO100 systematically in children with serious brain tumors."

NEO100 is a highly purified form of perillyl alcohol administered intranasally. Its delivery approach is designed to provide a non-invasive route to the brain. NEO100 remains investigational, and its safety and efficacy in pediatric patients have not been established.

The treatment builds on NeOnc’s expanding development activities in Abu Dhabi. In June 2026, the Company announced that the Department of Health – Abu Dhabi had granted IND authorization for NEO100 across its NEO100-01, NEO100-02 and NEO100-03 protocols, encompassing adult Phase 1 through Phase 2 studies and a pediatric Phase 1 and Phase 1b pathway pending further protocol review. In March 2025, NeOnc announced that the U.S. Food and Drug Administration had granted Rare Pediatric Disease Designation to NEO100 for pediatric-type diffuse high-grade gliomas. These authorizations and designations do not constitute approval for commercial use.

(Press release, Neonc, OCT 16, 2026, View Source [SID1234673536])

On October 16, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of an alternative dosing schedule for Libtayo (cemiplimab) across all approved indications.

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Specifically, the CHMP’s recommendation supports an extended dosing regimen of higher-dose Libtayo (700 mg) administered as a 30-minute intravenous infusion every six weeks, after an initial 12-week regimen of Libtayo 350 mg administered as a 30-minute intravenous infusion every three weeks. Additionally, the positive opinion supports a 15- to 30-minute infusion option for patients receiving Libtayo 350 mg every three weeks, if their first infusion at this dose level was well tolerated when administered over 30 minutes, which could cut treatment time by up to half.

The positive CHMP opinion is supported by comprehensive pharmacokinetic and pharmacodynamic modeling and simulation data, integrated with clinical safety and efficacy data from Libtayo’s clinical development program. The European Commission (EC) is expected to make a final decision on the application in the coming months, which would allow for this dosing regimen to be applied across all six approved indications in the European Union (EU).

The Libtayo 700 mg every six-week dosing option is already approved in the EU for use after an initial 12 weeks as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. Across all other approved indications, an alternate dosing regimen remains including Libtayo 350 mg every three weeks administered as an intravenous infusion over 30 minutes.

(Press release, Regeneron, OCT 16, 2026, View Source [SID1234673535])

On October 16, 2026 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported that the Company will present updated data from a Phase 1/2 study of vopimetostat in combination with daraxonrasib or zoldonrasib in patients with MTAP deleted RAS mutant (MTAPdel/RASmut) metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, which will be held October 23-27, 2026 in Madrid, Spain.

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Abstracts will be available on the ESMO (Free ESMO Whitepaper) website on Monday, October 19, 2026,12:05 am CEST. The data cutoff in the abstract is as of April 3, 2026. The poster presentation will include updated data.

Abstract accepted for poster presentation

Title: A Phase 1/2 study of vopimetostat in combination with daraxonrasib or zoldonrasib in patients with MTAP deleted RAS mutant (MTAPdel/RASmut) metastatic PDAC and NSCLC
Abstract #: 3149P
Presenter: Alexander I. Spira, MD, PhD, FACP (NEXT Oncology, Fairfax, United States of America)
Date, Time: Sunday, October 25, 2026, 12:00 – 12:45 pm CEST

PDAC Investor Webcast and Conference Call Information
The Company will host a PDAC focused investor webcast to discuss these data at 7:30 am ET on Friday, October 23, 2026. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.tangotx.com. The webcast will be available for replay for at least 30 days on the Company website. Analysts who wish to join the teleconference and participate in Q&A should register here.

(Press release, Tango Therapeutics, OCT 16, 2026, View Source [SID1234673534])