On October 18, 2025 SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing next-generation immunotherapies for infectious diseases and their associated cancers, reported the presentation of first-in-human clinical data for SCG142 in an investigator-initiated Phase I trial (NCT06544720) in patients with recurrent or metastatic HPV-associated carcinomas. The poster will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 in Berlin, Germany, on Saturday, 18 October 2025.

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This ongoing first-in-human trial evaluates the safety, tolerability and preliminary efficacy of SCG142, a novel human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy armoured with a TGFβRII-41BB chimeric switch receptor. Eligible patients are HLA-A*02:01-positive with advanced HPV16- or HPV52-positive carcinomas who have progressed on or were intolerant to at least one prior systemic therapy. Key endpoints include safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. As of the data cut-off, tumor shrinkage was observed in all seven treated patients, resulting in a disease control rate (DCR) of 100%. Four of the seven patients (57%) achieved >30% tumor reduction, including two confirmed partial responses (PR) and two unconfirmed PRs. No dose-limiting toxicities or serious adverse events were reported. These preliminary findings support continued clinical development of SCG142.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with promising clinical activity." said Prof. Dr. Yang Li, Director of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University. "We’re excited that tumor shrinkage was observed in all seven treated patients and that SCG142 was well tolerated. These encouraging preliminary findings underscore the potential of SCG142 to provide new solutions for patients in a variety of HPV16 and HPV52 expressing cancers and support further evaluation in larger patient cohorts", she added.

SCG142 was isolated with GianTCRTM, SCG’s proprietary TCR screening platform with the ability to identify fully natural TCRs with high affinity and high avidity properties as well as potent antiviral and anti-tumor effects against infection-related solid tumors accompanied by a lower risk of off-target toxicity. "We are delighted that the excellent preclinical profile of our HPV-E7-specific TCR – including high avidity and dual functionality in both CD8+ and CD4+ T cells – has translated into clinical activity with SCG142" added Dr. Susanne Wilde, VP, Head of Preclinical Research of SCG Cell Therapy.

Besides SCG142, SCG is also advancing SCG101, a hepatitis B virus (HBV)-specific TCR T cell therapy for the treatment of HBV-related hepatocellular carcinoma (HCC).

(Press release, SCG Cell Therapy, OCT 18, 2025, View Source [SID1234656750])

On October 18, 2025 Astrazeneca reported positive results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate. The trial compared Enhertu followed by THP with dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment.

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In DESTINY-Breast11, Enhertu followed by THP resulted in a pCR rate of 67.3% compared with 56.3% for ddAC-THP, representing a pCR rate improvement of 11.2%. Improvement in pCR rates was observed across both hormone receptor (HR)-positive and HR-negative subgroups (HR-positive: 61.4% versus 52.3%; HR-negative: 83.1% versus 67.1%). Additionally, after surgery, 81.3% of patients who received neoadjuvant treatment in the Enhertu followed by THP arm had no or minimal residual invasive cancer (residual cancer burden [RCB] 0+I) detected in the resected breast or lymph node tissue compared to 69.1% of patients in the comparator arm.

The secondary endpoint of event-free survival (EFS) was not mature at the time of this analysis (4.5% maturity at data cutoff); however, an early analysis showed a trend favouring Enhertu followed by THP versus ddAC-THP (hazard ratio 0.56; 95% CI 0.26-1.17).

Nadia Harbeck, MD, PhD, Director of Breast Center, Cancer Department of OB&GYN and CCC Munich, LMU University Hospital, Germany and principal investigator for the trial, said: "For patients with early breast cancer who are at high risk of disease recurrence, using the most effective treatment option at the earliest opportunity is critical to prevent recurrence, optimise safety and improve the potential for cure. In the DESTINY-Breast11 trial, more than two thirds of patients had a pathologic complete response with trastuzumab deruxtecan followed by THP, suggesting a potential new standard of care in the neoadjuvant setting for patients with high-risk, HER2-positive early breast cancer."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The goal of treatment in the early breast cancer setting is to provide patients with the best possible chance for cure whilst optimising the tolerability of the treatment regimen. The impressive pathologic response rates and favourable safety profile seen with Enhertu followed by THP in DESTINY-Breast11 have the potential to transform treatment in the neoadjuvant setting and underscore the importance of bringing Enhertu into earlier stages of HER2-positive disease."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "While achieving a pathologic complete response in HER2-positive early-stage breast cancer is critical for reducing disease recurrence and improving long-term prognosis, approximately half of patients still show evidence of residual disease following surgery with currently available neoadjuvant treatment options. The results from DESTINY-Breast11 show that treatment with Enhertu followed by THP prior to surgery resulted in no evidence of residual invasive disease in two thirds of patients, illustrating the first treatment regimen in more than a decade to significantly improve outcomes in the earliest treatment setting for HER2-positive breast cancer."

Summary of Results: DESTINY-Breast11i,ii

Efficacy Measure

Enhertu (5.4 mg/kg; 4 cycles) followed by THP (4 cycles) (n=321)

ddAC (4 cycles) followed by THP (4 cycles)
(n=320)

pCR

pCR rate, %iii

67.3

56.3

ΔpCR,% (95% CI)iii,iv

11.2 (4.0-18.3)

p=0.003

HR-positive subgroup pCR rate, %iii

61.4

52.3

ΔpCR, % (95% CI)

9.1 (0.2-17.9)

HR-negative subgroup pCR rate, % iii

83.1

67.1

ΔpCR, % (95% CI)

16.1 (3.0-28.8)

RCB (0+I)v

RCB (0+I rate), %

81.3

69.1

ΔRCB, %

12.2

RCB-I rate, %

68.8

57.5

RCB-0 rate, %

12.5

11.6

HR-positive subgroup RCB (0+I) rate, %

78.0

64.7

ΔRCB, % (95% CI)

13.3

HR-positive RCB-I rate, %

63.1

52.8

HR-positive RCB-0 rate, %

14.8

11.9

HR-negative subgroup RCB (0+I) rate, %v

90.4

81.2

ΔpCR, % (95% CI)

9.2

HR-negative RCB-I rate, %

84.3

70.6

HR-negative RCB-0 rate, %

6.0

10.6

EFSvi

2-year EFS, %

Hazard ratio (95% CI)

96.9

93.1

0.56 (0.26, 1.17)

THP, paclitaxel, trastuzumab and pertuzumab; ddAC, dose-dense doxorubicin and cyclophosphamide; pCR, pathologic complete response; HR, hormone receptor; CI, confidence interval; RCB (0+I), residual cancer burden; EFS, event-free survival

i Data cut-off 12 March 2025; median duration of follow up was 24.2 months with Enhertu followed by THP and 23.6 months with ddAC-THP
ii Based on blinded central review
iii pCR responders were defined as patients who only received randomised study treatment (at least one dose) and had pCR
iv Stratified Miettinen & Nurminen method; p value crossed the 0.03 prespecified boundary
v RCB is based on raw data and is not corrected for non-starters, or any bridging/off study neoadjuvant treatment; therefore, there may be differences between pCR and RCB-0
vi EFS was 4.5% mature at interim analysis

The safety profile of Enhertu followed by THP in DESTINY-Breast11 was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu followed by THP showed a favourable safety profile compared with ddAC-THP with reduced rates of Grade 3 or higher adverse events (AEs) (37.5% versus 55.8%), serious AEs (10.6% versus 20.2%), treatment interruptions (37.8% versus 54.5%) and left ventricular dysfunction (1.3% versus 6.1%).

Rates of interstitial lung disease (ILD) were low and similar between arms with ILD events occurring in 4.4% of patients in the Enhertu followed by THP arm compared with 5.1% in the ddAC-THP arm. The majority of ILD events were low Grade (Grade 1 and 2). There was one Grade 3/4 event in the Enhertu followed by THP arm and five Grade 3/4 events in the ddAC-THP arm. There was one Grade 5 ILD event in each arm as determined by an independent adjudication committee.

DESTINY-Breast11 results (abstract #291O) will be presented today during Presidential Symposium I, alongside the results from the DESTINY-Breast05 Phase III trial (abstract #LBA1) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress in Berlin, Germany. The DESTINY-Breast11 results will also be published in the Annals of Oncology in parallel with ESMO (Free ESMO Whitepaper).

A supplemental Biologics License Application for Enhertu followed by THP based on the results from DESTINY-Breast11 is currently under review by the US Food and Drug Administration (FDA).

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

Notes

HER2-positive early 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 breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer.2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.2 Approximately one in five cases of breast cancer are considered HER2-positive.3

Approximately one in three patients with HER2-positive early breast cancer are considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis.4 For patients with HER2-positive early breast cancer, achieving pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR.6-10

The current standard of care in the HER2-positive neoadjuvant setting in many regions of the world consists of combination chemotherapy regimens.11 These regimens often include anthracyclines, which can be challenging for patients to tolerate and may result in long-term cardiotoxicity, reinforcing the need for new treatment options.11-13

DESTINY-Breast11
DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4 mg/kg) monotherapy or Enhertu followed by THP (paclitaxel, trastuzumab and pertuzumab) versus ddAC-THP in patients with high-risk (lymph node positive [N1-3] or primary tumour stage T3-4), locally advanced or inflammatory HER2-positive early-stage breast cancer.

Patients were randomised 1:1:1 to receive either eight cycles of Enhertu monotherapy; four cycles of Enhertu followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.

The Enhertu monotherapy arm was closed early following a recommendation from the Independent Data Monitoring Committee (IDMC). The recommendation was based on multiple factors including a lower pCR rate, low likelihood that Enhertu alone would be superior to ddAC-THP, and timing of surgery. The recommendation was not related to safety.

The primary endpoint of DESTINY-Breast11 is rate of pCR (absence of invasive disease in the breast and lymph nodes). Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.

DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway (datopotamab deruxtecan), and next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer.

To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab).

(Press release, AstraZeneca, OCT 18, 2025, View Source [SID1234656783])

On October 17, 2025 XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA) and LAVA Therapeutics N.V. ("LAVA") (Nasdaq: LVTX) reported that they have reached an agreement to amend their previously announced definitive share purchase agreement (the "Purchase Agreement," and such amendment, the "Amendment").

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Under the Amendment, LAVA shareholders who tender their shares will now receive (i) an initial cash amount per share of $1.04 (the "Cash Amount," as compared to the range between $1.16 and $1.24 that was originally agreed), plus (ii) a non-transferable contingent value right ("CVR") per share representing the right to receive certain cash payments, including (A) the previously announced rights to receive, among other things, 75% of the net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs, plus (B) a new right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities (the "Offer"). In addition, LAVA and XOMA Royalty have agreed to amend LAVA’s minimum net-cash closing condition to be $24.5 million, compared to the previous minimum net-cash closing condition of $31.5 million. LAVA and XOMA Royalty are entering into the Amendment in light of their current understanding of potential liabilities, associated expenses, and the most recent estimates of LAVA’s expected cash balance at closing. LAVA will be filing the Amendment, including the amended form of CVR, on a Current Report on Form 8-K.

The Offer, which was previously scheduled to expire one minute after 11:59 p.m. Eastern Time on October 17, 2025, has been extended until one minute after 11:59 p.m. Eastern Time on November 12, 2025, unless the Offer is further extended or earlier terminated. The proposed acquisition is expected to close in the fourth quarter of 2025, subject to customary closing conditions.

LAVA shareholders who previously have tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the Offer. LAVA shareholders have signed support agreements to tender their shares in the Offer prior to the expiration date and support the Offer.

The closing of the Offer is subject to certain conditions, including the tender of LAVA common shares representing at least 80% (or, in certain cases, 75%) of LAVA’s issued and outstanding shares, the condition that certain resolutions are adopted by LAVA’s shareholders meeting, a minimum net-cash balance at closing, and other customary closing conditions. Following a subsequent offering period, LAVA will undergo a corporate reorganization designed to result in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and non-transferable contingent value right consideration per share as is provided in the Offer, subject to applicable withholding taxes.

LAVA intends to reconvene the Extraordinary General Meeting of Shareholders to approve matters related to the transactions between LAVA and XOMA Royalty including the resolutions mentioned above (the "EGM") to 2:00 p.m. (Central European Summer Time) on November 7, 2025 at the offices of NautaDutilh N.V., located at Beethovenstraat 400, 1082 PR Amsterdam, the Netherlands. The EGM was previously scheduled to occur on September 30, 2025. LAVA will file a revised definitive proxy statement related to the reconvened EGM.

(Press release, Lava Therapeutics, OCT 17, 2025, View Source [SID1234656734])

On October 17, 2025 Boehringer Ingelheim reported positive results from the Beamion LUNG-1 trial evaluating HERNEXEOS (zongertinib tablets) in treatment-naïve patients (N=74) with advanced non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations in the tyrosine kinase domain (TKD). HERNEXEOS demonstrated efficacy with a confirmed objective response rate (ORR) of 77%. The data were featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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"Non-small cell lung cancer with HER2 activating mutations is a highly heterogeneous and aggressive disease which in the past has made it hard to find a targeted treatment offering significant clinical benefit," said the presenting author, Prof. Sanjay Popat, MD, PhD, Consultant Medical Oncologist, Head of the Lung Unit, and Lead for the Lung Cancer Research Programme at the Royal Marsden Hospital. "A response rate of 77% regardless of mutation subtype and a median time to response of 1.4 months indicate that zongertinib elicited a rapid response in treatment-naïve patients with HER2 TKD-mutant NSCLC, making it a promising future targeted treatment option in this setting."

Of the responders (77%), 8% of patients achieved complete response, 69% achieved partial response and 96% of patients achieved disease control. At data cut-off, median values for duration of response (DoR) and progression-free survival (PFS) were not yet mature, with 47% of patients remaining on treatment and encouraging 6-month rates for DoR of 80% and PFS of 79%.

Data presented at ESMO (Free ESMO Whitepaper) demonstrated a manageable safety profile for HERNEXEOS in treatment-naïve patients, with a similar pattern of adverse events (AEs) to that observed and reported in previously treated patients. Adverse events led to dose reductions in 11 patients (15%) and dose discontinuations in 7 patients (9%). The most commonly reported AEs were grade 1 diarrhea and rash.

HERNEXEOS was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) in China for the first-line treatment of adult patients with unresectable or metastatic NSCLC whose tumors have HER2 TKD activating mutations.

Beamion LUNG-2 (NCT06151574), a Phase III randomized study evaluating HERNEXEOS as a first-line therapy versus standard of care in patients with unresectable, locally advanced or metastatic HER2-mutant NSCLC, is currently enrolling.

"We see a significant unmet need in the first-line setting for patients with HER2-mutant advanced NSCLC where there are currently no targeted treatments approved. These data are extremely encouraging and reinforce our belief in the potential of HERNEXEOS for treatment-naïve patients with advanced non-small cell lung cancer with activating HER2 mutations," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "Employing our dual approach to oncology, we are advancing both cancer cell and immune cell-directed therapies to pioneer breakthroughs for patients."

HER2 (ERBB2)-mutant NSCLC is a disease characterized by its aggressive nature and poor prognosis. Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.3

About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.4 The condition is often diagnosed at a late stage,6 and fewer than 3 in 10 patients are alive five years after diagnosis.6 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.7,8,9 There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.3

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2). HERNEXEOS was recently approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The U.S. FDA also granted Breakthrough Therapy Designation for HERNEXEOS for use in a first-line setting.

About the Beamion clinical trial program
Beamion LUNG-1 (NCT04886804): An open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 (ERRB2) alterations. The study has two parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 (ERRB2) gene) for whom previous treatment was not successful. The second part is open to people with advanced NSCLC with a specific mutation in the HER2 (ERBB2) gene. Beamion LUNG-2 (NCT06151574) is a Phase III, open label, randomized, active-controlled study in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) TKD mutations to evaluate zongertinib compared with standard of care. The study will enroll 416 patients who will be randomly assigned to receive either zongertinib or standard of care treatment. Beamion LUNG-3 (NCT07195695) is an interventional Phase III, randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable NSCLC that has HER2 TKD mutations. Its objective is to test whether zongertinib helps people with surgically removed NSCLC with HER2 mutations compared with standard treatment and will enroll 400 patients.

(Press release, Boehringer Ingelheim, OCT 17, 2025, View Source [SID1234656751])

On October 17, 2025 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.

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"For people living with CML, long-term therapy can be physically and emotionally demanding, and many face challenges in reaching treatment milestones without compromising quality of life," said David FitzGerald, Member of the CML Advocates Network. "The availability of more treatment options earlier in the care pathway is a welcome development that brings forward additional possibilities for patients and their healthcare teams to choose approaches that best support both clinical goals and patient well-being."

The positive CHMP opinion is based on data from the Phase III ASC4FIRST trial, which compared Scemblix with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in patients with newly diagnosed Ph+ CML-CP1,2. In the trial, Scemblix demonstrated superior major molecular response (MMR) rates when compared against all TKIs (imatinib, nilotinib, dasatinib and bosutinib) and also when compared against imatinib alone1,2. Patients treated with Scemblix also required fewer dose reductions and experienced half the rate of adverse events leading to discontinuation1,2.

"To give patients newly diagnosed with CML the best chance to reach key efficacy milestones while maintaining quality of life, it is critical to intervene early with a more selective treatment that combines superior efficacy with tolerability," said Professor Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology at Jena University Hospital, Germany. "If approved, Scemblix could provide patients with a well-tolerated option that may deliver faster, deeper and longer-lasting molecular response with fewer treatment discontinuations due to adverse events, compared with available first-line treatments — potentially paving the way for more patients to reach treatment-free remission."

Scemblix is approved in earlier lines in more than 20 countries, including the US, Japan and China5,6. Scemblix is recommended for the treatment of patients with newly diagnosed Ph+ CML-CP by the 2025 European LeukemiaNet recommendations for the management of CML and by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)7,8. Since 2021, Scemblix has been a standard of care (SoC) in more than 80 countries for patients previously treated with two or more TKIs5,6,9.

"People newly diagnosed with CML need treatments that deliver both better efficacy and excellent tolerability to achieve early, deep molecular response, which is critical to achieve long-term outcomes like treatment-free remission," said Patrick Horber, M.D., President, International, Novartis. "Scemblix is the only treatment that has demonstrated superior efficacy and tolerability compared to current first-line treatments. Today’s positive CHMP opinion marks a major milestone in our 25-year journey to improve CML care and could help establish a new standard of care in Europe."

Following the CHMP’s recommendation to approve Scemblix for the treatment of adults with Ph+ CML-CP in all lines of treatment, the European Commission (EC) will make a final decision within two months.

About ASC4FIRST
ASC4FIRST (NCT04971226) is a Phase III, head-to-head, multi-center, open-label, randomized study of oral Scemblix 80 mg QD vs. investigator-selected first- or second-generation TKIs (imatinib, nilotinib, dasatinib or bosutinib) in 405 adult patients with newly diagnosed Ph+ CML-CP10. The trial met both primary endpoints with Scemblix demonstrating superior MMR rates at week 48 vs. investigator-selected SoC TKIs (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%)1,10. Additionally, Scemblix showed a numerical improvement versus the 2G TKI stratum (66% vs. 57.8%)1,10. At week 96, Scemblix demonstrated sustained superior MMR vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%)2.47.1%), meeting both ASC4FIRST key secondary endpoints2.

About Scemblix (asciminib)
Scemblix is the first CML treatment that works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature)11-13. Other currently approved CML treatments are TKIs that target the ATP-binding site (ATP-competitive)13.

Scemblix is approved to treat newly diagnosed adults with Ph+ CML-CP in more than 20 countries, including the US, Japan and China4,5. It is also approved in more than 80 countries, including the EU, to treat those with Ph+ CML-CP who have previously been treated with two or more TKIs 5,6,7. In some countries, including the US, Scemblix is also approved in patients with Ph+ CML-CP with the T315I mutation5-7.

Scemblix has been studied across multiple treatment lines for Ph+ CML-CP, both as a monotherapy and as a combination therapy.

(Press release, Novartis, OCT 17, 2025, View Source [SID1234656735])