Latest news with #ASCO2025
Medscape
6 hours ago
- Health
- Medscape
Key Abstracts in Early-Stage NSCLC From ASCO 2025
Dr Jonathan Goldman of the University of California, Los Angeles, highlights key abstracts in early-stage NSCLC from ASCO 2025. Dr Goldman begins with updated results from CheckMate 816, comparing neoadjuvant chemotherapy (chemo) vs chemo + nivolumab. Median overall survival (OS) in the nivolumab arm remains unreached vs 73.7 months with chemo alone. Event-free survival (EFS) is durable at 59.6 vs 21.1 months, as evidenced by 5-year EFS of 49% in the combination arm. Next, he reviews the NeoADAURA trial evaluating neoadjuvant osimertinib ± chemo in resectable EGFR-mutated stage II-IIIB NSCLC. Major pathologic response was higher in osimertinib-containing arms (26% and 25%) vs 2% in the chemo arm, although long-term outcomes remain pending. Dr Goldman also discusses the SWOG/NRG S1914 trial of perioperative stereotactic body radiotherapy ± atezolizumab, which did not show improvements in OS or progression-free survival (PFS). He then highlights a prospective, low-dose CT screening study of the Mississippi Delta cohort, which showed a 4.7% lung cancer detection rate overall and 4.5% in patients with incidental pulmonary nodules — underscoring the utility of low-dose CT as a modality in early detection. In closing, he reports on two studies in small cell lung cancer. The IMforte study showed that lurbinectedin + atezolizumab in 1L maintenance improved PFS (HR, 0.54). In the DeLLphi-304 study, second-line tarlatamab improved OS compared to chemo (HR, 0.6), which is a potentially practice-changing update.
Medscape
8 hours ago
- Health
- Medscape
EGFR+ NSCLC: Experts Weigh Risk vs Reward at ASCO 2025
This transcript has been edited for clarity. Coral Olazagasti, MD: Hello. My name is Coral Olazagasti, and I'm a thoracic oncologist at Sylvester Comprehensive Cancer Center at the University of Miami. Joining me today is my friend and colleague, Maria Velez, a clinical instructor at UCLA, and also my other friend and colleague, Ana Velázquez Mañana, who's an assistant professor of medicine at UCSF. Today we are super excited because we are speaking about the ASCO 2025 Annual Meeting here in Chicago. We just came out from the oral abstracts for the metastatic setting for non-small cell lung cancer and we want to share some of the data that we learned. We want to start the discussion here today about EGFR -mutant disease in the second-line setting. We're going to start with Maria. Do you want to tell us a little bit about the HERTHENA-Lung02 study? Maria A. Velez, MD, MS: Sure. HERTHENA-Lung02 was a study that evaluated HER3-DXd, which is an antibody-drug conjugate (ADC), in the second-line setting for patients with previously treated EGFR -sensitizing mutations. It was an open-label study where patients received either the HER3-DXd or the investigator's choice chemotherapy, and the primary endpoint was median progression-free survival. The results showed that the median progression-free survival for patients who received HER3-DXd was 5.8 months whereas the median for the chemotherapy arm was 5.4 months. Even though it was a statistically significant difference, it was not a very clinically meaningful difference, with a huge implication that 100% of the patients in this study had treatment-related adverse events and some patients experienced interstitial lung disease (ILD). All in all, taking these data into account, even though there's a huge need in the treatment landscape for second-line EGFR -mutant patients, I think this ADC did not really show a substantial enough clinically meaningful benefit and had a large amount of toxicity. Olazagasti: Not to say that this study didn't show any overall survival (OS) benefit. We're talking about a drug that's not really giving patients a longer life and is also giving many side effects, like you mentioned — a large amount of discontinuation due to ILD, and so much toxicity without that benefit there. I think we'll table that regimen for now. Do you agree? Velez: I agree. Ana I. Velázquez Mañana, MD, MSc: I agree. Clearly, it's disappointing to see the results of not beating chemotherapy in the second-line setting, but I do think that potentially there is a role in the third line or afterwards. We know that patients are going to be getting chemotherapy and amivantamab in the second-line setting. There is a need for further drugs and interventions in the third line if patients don't have other AGAs [actionable oncogenic alterations] or other drivers that we can use targeted therapies for. I am hesitant to give up completely on the drug. I do agree it's quite toxic and very disappointing to unfortunately see these results in the second line. Olazagasti: I agree. Moving on to the next study — Ana, do you want to talk to us about the SACHI study? Velazquez Mañana: The SACHI study was an open-label, randomized trial of savolitinib plus osimertinib vs platinum doublet chemotherapy in patients who, post EGFR TKI, had progressed in the second line and had a MET amplification. We know that MET amplifications are an extremely common mechanism of resistance to EGFR TKI-targeted therapies. Interestingly, in this study, which brings a little bit of heterogeneity, they included patients treated with first- and second-generation EGFR TKIsas well as those treated with third-generation TKIs like osimertinib, which would be our standard of care. They did look to make sure those were T790M negative, those treated with earlier generations. Interestingly, the results on the primary endpoint of progression-free survival (PFS) showed a benefit of 8.2 months in the combination vs 4.5 months in patients treated with doublet chemotherapy. That [benefit] was maintained in both patients treated with earlier-generation TKIs as well as those treated with third-generation TKIs. It also had some efficacy data and overall response rates of 63.2% vs 36.2%. Definitely, as we know, using a MET-targeted therapy is helpful. We already know from the United States that they use an approval in the second line of chemotherapy and amivantamab. That approach leads to responses in patients after EGFR TKIs. I think it's an interesting approach, obviously, to think of sparing patients from chemo in that second line and combining two TKIs, but we have to see if that is better than chemo with amivantamab would've been, which would've been our standard of care here. With savolitinib, we know what the adverse events are. It's a drug that's been approved in China now for years. It's not used in the United States, but I think, based on these studies, it's interesting to see what other studies will come in the future and whether this is a potential approach for us to use. Olazagasti: Definitely it's interesting. I feel like EGFR is the cool kid on the block now. We have so many options and so many studies looking into it, and it's just interesting to see what the future holds and what else is going to come into play. Continuing down the line of the EGFR second-line studies, I'm going to talk about the OptiTROP-Lung03 study. This study uses sacituzumab tirumotecan. It's a phase 3 study of EGFR mutants. Patients had to receive not only TKI but also platinum therapy, and they were randomized into using sacituzumab tirumotecan — we're going to call it sac-TMT because this is very hard to pronounce — vs docetaxel. The primary endpoints of the study were overall response rates, and secondary endpoints were PFS and OS. The study showed that the overall response rate was 45.1% vs 15.6% in the docetaxel arm. Also, there was a PFS benefit. The median PFS was 6.9 compared to only 2.8 in the chemo arm. Even though the median OS is still ongoing, with the median not reached yet, at 12 months there was an OS of 72.8% compared to 43.2%. I think this drug has been approved in China, and I know that in December it received breakthrough FDA designation in the United States. We'll see, again, what the future holds. Do you have any thoughts about this? Velazquez Mañana: We've been seeing from the different TROP2 ADCs that clearly they have a role in EGFR -driven lung cancer. I think it's exciting to see another one. Unfortunately, there are drugs that have many toxicities, so they are hard to manage for patients. Again, on this one I am a little bit conflicted with what the comparator arm is, and one that not necessarily would be our current standard of care. So we are having a large amount of new development and newer drugs, but because of how long it takes to run trials and the newer approvals that come, it's hard to make comparisons and decisions of which ones you should select and the timing of them. Hopefully, we'll get more data in the future. Olazagasti: I think that's the general consensus. And the dilemma that we have right now in the EGFR space, because we have so many approved options, is that there's really not a great sequential treatment. It's not really a one-size-fits-all approach. Some people use osimertinib alone in the first line. Some people use the FLAURA2 study with osimertinib and chemo. Some people prefer the MARIPOSA regimen. These are all pretty decent options, and so bringing these other drugs into the second- and third-line setting, how do we do the sequencing? I think that's really where the dilemma and the problems are going to come about. Institutions may have different orders and different preferences, but I think in these situations it's also important to take each patient into consideration individually because, like we have already mentioned, it's not only about the treatment and then the benefits, but also the side-effect profile. This one in particular didn't have any ILDs compared to in HERTHENA where they had a high rate, but we have to really look into toxicities because it's not only survival for patients and PFS; it's really about quality of life, too. With this great discussion, I think we're going to wrap up for today. Thank you to my friends and colleagues for joining me. Again, this is Coral Olazagasti, speaking from the 2025 ASCO Annual Meeting here in Chicago.
Yahoo
9 hours ago
- Health
- Yahoo
Transgene completes initial screening in Phase II part of TG4050 vaccine trial
Transgene has completed the initial subject screening for the Phase II segment of its Phase I/II trial of individualised neoantigen therapeutic vaccine, TG4050, as a monotherapy in the adjuvant treatment of human papillomavirus (HPV)-negative squamous head and neck cancers. The vaccine is based on the myvac platform powered by its partner NEC's AI to enhance antigen selection. During the Phase I portion of the trial, all subjects treated with the vaccine remained disease-free post a minimum follow-up of two years, demonstrating clinical proof of principle. Translational data indicated that these subjects showed sustained T cell responses at 24 months. Meeting all trial endpoints, the findings were shared at the American Society of Clinical Oncology (ASCO 2025) annual meeting. The company anticipates completing the randomisation of all subjects in the Phase II part by the end of this year, after a second screening carried out post-surgery and adjuvant radiotherapy. Around 80 subjects who have completely responded to adjuvant therapy are expected to be enrolled and randomised in the Phase I/II trial. The first immunogenicity data from the Phase II part are projected to be available in the second half of 2026, with preliminary efficacy data anticipated in the second half of 2027. The trial is assessing the treatment benefits of the vaccine in individuals at risk of relapse. So far, 32 evaluable patients have been included in the Phase I part, with the Phase II continuing globally. Transgene chief medical officer Dr Emmanuelle Dochy said: 'Timely completion of first patient screening of the Phase II part of our Phase I/II trial is an important milestone for Transgene and brings us one step closer to providing a new treatment option for patients living with operable squamous head and neck cancer. 'With meaningful data readouts expected over the next two years, we are preparing to deliver important data for TG4050 and, at the same time, explore its wider potential. We are grateful to the patients, their families, investigators, and clinical staff whose commitment made this achievement possible.' "Transgene completes initial screening in Phase II part of TG4050 vaccine trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Medscape
2 days ago
- Health
- Medscape
ASCO 2025: Clinical Impact of New Data in Advanced NSCLC
Isabel Preeshagul, DO, comments on treatment updates in advanced non-small cell lung cancer shared at ASCO 2025, emphasizing their impact on patients. The KRYSTAL-7 study showed that adagrasib combined with pembrolizumab achieved a 43% response rate in KRAS G12C-mutant patients, especially those with PD-L1 over 50%, though liver toxicity was a key concern. The REZILIENT1 study highlighted zipalertinib's activity in EGFR exon 20 insertion–positive patients, with encouraging CNS responses and manageable side effects like paronychia. Lastly, the COCOON study showed that a proactive dermatologic regimen significantly reduced skin toxicities from amivantamab, though practical challenges remain in balancing effectiveness with patient burden.
Yahoo
5 days ago
- Health
- Yahoo
Subgroup Analysis of Cadonilimab as First-Line Therapy for Advanced Cervical Cancer Reported in an Oral Presentation at ASCO 2025
HONG KONG, June 15, 2025 /PRNewswire/ -- Akeso, Inc. ( ("Akeso" or the "Company") presented the subgroup analysis data from the Phase III COMPASSION-16 trial, evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in the first-line treatment of advanced, recurrent, or metastatic cervical cancer. The data was featured as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The subgroup analysis demonstrated that cadonilimab treatment significantly improved progression-free survival (PFS) and overall survival (OS) across different patient subgroups, including: levels of PD-L1 expression, prior treatment with concurrent chemoradiotherapy (CCRT), bevacizumab use, and age of the patients (≥65, <65). These results further demonstrate the clinical value and the global women's health impact of cadonilimab in advancing thetreatment standart for advanced cervical cancer. The results of the COMPASSION-16 study were previously published in The Lancet and presented at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting. The Lancet publication and the IGCS presentation disclosed that cadonilimab, in combination with platinum-based chemotherapy (with or without bevacizumab), significantly extended survival in both PD-L1-positive and PD-L1-negative patient populations (mOS HR 0.64, P=0.0011), and reduced the risk of disease progression and death (mPFS HR 0.62, P<0.0001). At the 2025 ASCO annual meeting, the study's principal investigator, Professor Xiaohua Wu from the Fudan University Shanghai Cancer Center, presented the subgroup analysis findings from the COMPASSION-16 study, with data cut-off as of April 30, 2024. Key Findings: Significant Reduction in Mortality Risk Across All Patient Subgroups, Regardless of PD-L1 Expression: In the CPS<1 group, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.65), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.77). In the CPS≥1 group, mPFS was 14.7 months in the cadonilimab arm vs. 8.3 months in the control arm (HR=0.62), and mOS was not reached in the cadonilimab arm vs. 22.7 months in the control arm (HR=0.69). In the CPS≥10 group, mPFS was 17.1 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.54), and mOS was not reached in the cadonimab arm vs. 29 months in the control arm (HR=0.68). Clinical Benefit in PFS and OS Regardless of Prior CCRT Treatment: In patients previously treated with CCRT, mPFS was 16.1 months in the cadonilimab arm vs. 7.9 months in the control arm (HR=0.55), and mOS was not reached in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.54). Clinical Benefit in PFS and OS Regardless of Bevacizumab Use: In real-world settings, approximately 40% of patients are considered unsuitable for bevacizumab due to underlying conditions or bleeding/perforation risks. Cadonilimab demonstrated clinically meaningful improvements in both PFS and OS, whether or not bevacizumab was included in the treatment. In the bevacizumab-naive groups, mPFS was 11.7 months in the cadonilimab arm vs. 6.7 months in the control arm (HR=0.44), and mOS was 28.2 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.5). Improvement in PFS and OS Across Age Subgroups, with Greater Efficacy in Patients ≥65 Years: In patients < 65 years, mPFS was 13.5 months in the cadonilimab arm vs. 9.5 months in the control arm (HR=0.68), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.69). In patients ≥ 65 years, mPFS was 12 months in the cadonilimab arm vs. 7.4 months in the control arm(HR=0.39), and mOS was 26.6 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.49). Cadonilimab Combined with Platinum Agents (Cisplatin/Carboplatin) Improves PFS and OS: In the cisplatin arm, mPFS was 14.7 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.49), and mOS was not reached in the cadonilimab arm vs. 23.9 months in the control arm (HR=0.43). In the carboplatin arm, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.72), and mOS was 27.8 months in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.82). In June 2022, cadonilimab was granted approval by the China National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer in patients who had previously failed platinum-based chemotherapy. This indication has since been included in the national reimbursement list. In September 2024, the use of cadonilimab in first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma was approved by the NMPA. The use of cadonilimab in first-line treatment for advanced, recurrent, or metastatic cervical cancer was approved by the NMPA in May 2025. In addition, cadonilimab is currently being evaluated in nearly 30 registrational/Phase III and Phase II clinical trials across a number of high-incidence cancers. Preliminary results show that cadonilimab demonstrates clinical benefit for patient populationsin both the positive and the negative PD-L1 expression groups, marking a significant advancement over existing immunotherapies. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. View original content: SOURCE Akeso, Inc.
