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67 Trials |
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67 Trials |  |
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- Libtayo (cemiplimab) / Regeneron
Occurrence of subacute cutaneous lupus erythematosus during therapy with the anti-PD-1 antibody cemiplimab (Hall E) - Jun 28, 2023 - Abstract #ADO2023ADO_143;
- || Libtayo (cemiplimab-rwlc) / Regeneron, Ordspono (odronextamab) / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: CLIO-1: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies (clinicaltrials.gov) - Jun 22, 2023
P1, N=62, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
N=172 --> 62 | Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
- | Libtayo (cemiplimab) / Regeneron
Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker, Metastases: Variable Outcome of Immunotherapy in Advanced Multiple Cutaneous Squamous Cell Carcinomas in Two Patients with Recessive Dystrophic Epidermolysis Bullosa. (Pubmed Central) - Jun 20, 2023
Our experience and the literature suggest that cemiplimab is an option in patients with RDEB if surgery is not. Somatic mutations and the immune microenvironment should be characterized to predict therapeutic response, particularly in aggressive undifferentiated tumours.
- ||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion: R2810-ONC-1620: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy (clinicaltrials.gov) - Jun 18, 2023
P2, N=138, Completed, Sponsor: Regeneron Pharmaceuticals
Somatic mutations and the immune microenvironment should be characterized to predict therapeutic response, particularly in aggressive undifferentiated tumours. Active, not recruiting --> Completed
- || Review, Journal, Checkpoint inhibition: Combination of epidrugs with immune checkpoint inhibitors in cancer immunotherapy: From theory to therapy. (Pubmed Central) - Jun 16, 2023
Subsequently, a diverse array of inhibitory agents under investigations targeted epigenetic modulators (Azacitidine, Decitabine, Vorinostat, Romidepsin, Belinostat, Panobinostat, Tazemetostat, Enasidenib and Ivosidenib, etc.) and immune checkpoints (Atezolizmab, Avelumab, Cemiplimab, Durvalumb, Ipilimumab, Nivolumab and Pembrolizmab, etc.) to increase anticancer responses were described and the potential mechanisms were further discussed. Finally, we summarize the findings of clinical trials and provide a perspective for future clinical studies directed at investigating the combination of epidrugs with ICIs as a treatment for cancer.
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Biomarker, Enrollment open, Trial completion date, Trial primary completion date, IO biomarker: A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Jun 13, 2023
P2/3, N=950, Recruiting, Sponsor: Regeneron Pharmaceuticals
Finally, we summarize the findings of clinical trials and provide a perspective for future clinical studies directed at investigating the combination of epidrugs with ICIs as a treatment for cancer. Not yet recruiting --> Recruiting | Trial completion date: May 2031 --> Oct 2031 | Trial primary completion date: May 2031 --> Nov 2029
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date, Monotherapy: R3767-ONC-2235: A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Jun 13, 2023
P2/3, N=850, Recruiting, Sponsor: Regeneron Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: May 2031 --> Oct 2031 | Trial primary completion date: May 2031 --> Nov 2029 Not yet recruiting --> Recruiting | Trial completion date: Nov 2028 --> Jan 2032 | Trial primary completion date: Nov 2028 --> Feb 2030
- ||| Review, Journal, Adverse events: Immunotherapy for keratinocyte cancers. Part II: Identification and management of cutaneous side effects of immunotherapy treatments. (Pubmed Central) - Jun 7, 2023
Different types of CAEs from immune checkpoint inhibitors have been associated with different oncologic outcomes in various primary cancer types, and this remains to be determined for KC patients. CAE characterization and management after immune checkpoint inhibitors in KC patients is a rapidly growing field that needs specific and prospective studies.
- |||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Clinical, Metastases: Significant durable response with fianlimab (anti-LAG-3) and cemiplimab (anti-PD-1) in advanced melanoma: post adjuvant PD-1 analysis #ASCO23 @ASCO @Regeneron @Mi_onc @angelesclinic (Twitter) - Jun 6, 2023
- | Trial primary completion date, Checkpoint inhibition, IO biomarker: Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) - Jun 6, 2023
P1, N=32, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
CAE characterization and management after immune checkpoint inhibitors in KC patients is a rapidly growing field that needs specific and prospective studies. Trial primary completion date: May 2023 --> May 2024
- ||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Clinical, Metastases: #melanomaorals #ASCO23 new combination of fianlimab with cemiplimab seems promising for metastatic/unresectable melanoma pts, even for patients with prior ICI exposure, increased AI risk for safety @OmidHamidMD (Twitter) - Jun 5, 2023
- |||||| Libtayo (cemiplimab) / Regeneron
Metastases: A head and neck oncologist crashing the melanoma/skin cancer party. 🤪👍🏼Durable responses and NO kidney rejection for mTOR/pred+Cemiplimab in KTRs with metastatic CSCC — 👀😱@evanlipson @DanaFarberNews @DanaFarber @ASCO #ASCO2023 (Twitter) - Jun 3, 2023
- ||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
@Mi_onc presenting data at #ASCO2023 of the @Regeneron combination cemiplimab and fianlimab in poor prognosis melanomas. @angelesclinic @CSCancerCenter (Twitter) - Jun 3, 2023
- ||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Phase classification, Monotherapy: A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) (clinicaltrials.gov) - Jun 2, 2023
P2, N=100, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial primary completion date: May 2023 --> May 2024 Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P2
- || Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients (clinicaltrials.gov) - May 31, 2023
P2, N=73, Recruiting, Sponsor: Regeneron Pharmaceuticals
Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P2 Trial completion date: Sep 2029 --> Feb 2031 | Trial primary completion date: Jul 2024 --> Apr 2025
- | Journal, Checkpoint inhibition, Real-world evidence, Real-world: Evaluation of uveitis events in real-world patients receiving immune checkpoint inhibitors based on the FAERS database. (Pubmed Central) - May 29, 2023
When ICIs were used in a combined way, uveitis signals became obviously stronger. Therefore, early ophthalmic monitoring is important when applying ICIs to patients, especially those with a tendency for uveitis, such as melanoma patients.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Checkpoint inhibition, Tumor mutational burden: A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer (clinicaltrials.gov) - May 26, 2023
P2, N=34, Recruiting, Sponsor: University of Southern California
Therefore, early ophthalmic monitoring is important when applying ICIs to patients, especially those with a tendency for uveitis, such as melanoma patients. Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Jun 2024
- Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, IO biomarker: DISCERN: Deep sequencIng in Cutaneous Squamous CEll caRciNomas (clinicaltrials.gov) - May 26, 2023
P2, N=10, Not yet recruiting, Sponsor: Peter MacCallum Cancer Centre, Australia
- ||| Libtayo (cemiplimab) / Regeneron
Regeneron touts ORR up to 63% for Libtayo, LAG-3 combo in melanoma #ASCO23 $REGN https://t.co/iayAbIFz8X (Twitter) - May 25, 2023
- | Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer (clinicaltrials.gov) - May 25, 2023
P2, N=34, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
Trial completion date: Jan 2024 --> Jun 2025 | Trial primary completion date: Jun 2023 --> Jun 2024 Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
- || Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion: Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (clinicaltrials.gov) - May 24, 2023
P2, N=25, Completed, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026 Active, not recruiting --> Completed
- ||| Libtayo (cemiplimab) / Regeneron
P3 data, Journal, Metastases: Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced Non-Small Cell Lung Cancer: 2-Year Follow-up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. (Pubmed Central) - May 22, 2023
P3
Active, not recruiting --> Completed At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels.
- ||| solnerstotug (SNS-101) / Sensei Biotherap
Enrollment open, Monotherapy: SNS-101-2-1: A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 22, 2023
P1/2, N=129, Recruiting, Sponsor: Sensei Biotherapeutics, Inc.
At protocol-specified final OS analysis with 28.4 months of follow-up, the EMPOWER-Lung 3 study continued to reveal benefit of cemiplimab plus chemotherapy versus chemotherapy alone in patients with advanced squamous or nonsquamous NSCLC, across programmed death-ligand 1 levels. Not yet recruiting --> Recruiting
- | Journal, Checkpoint inhibition: Do immune checkpoint inhibitors share the same pharmacological feature in the risk of cardiac arrhythmias? (Pubmed Central) - May 21, 2023
We found that ipilimumab was the only ICI associated with a reduced reporting frequency. Further high-quality studies are needed to confirm our results.
- || Opdivo (nivolumab) / Ono Pharma, BMS
P2 data, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Nivolumab for locally advanced and metastatic cutaneous squamous cell carcinoma (NIVOSQUACS study) - phase II data covering impact of concomitant hematological malignancies. (Pubmed Central) - May 21, 2023
This study demonstrated robust clinical efficacy of nivolumab in patients with locally advanced and metastatic cSCCs and a tolerability comparable to data of other anti-PD-1 antibodies. Favourable outcomes were obtained despite involving the oldest hitherto reported study cohort for anti-PD-1 antibodies and a significant proportion of CHM patients prone to high risk tumors and an aggressive course otherwise typically excluded from clinical trials.
- |||| solnerstotug (SNS-101) / Sensei Biotherap
New P1/2 trial, Monotherapy: SNS-101-2-1: A Study of SNS-101 (Anti VISTA) Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 18, 2023
P1/2, N=129, Not yet recruiting, Sponsor: Sensei Biotherapeutics, Inc.
- || Libtayo (cemiplimab-rwlc) / Regeneron, Praluent (alirocumab) / Sanofi, Regeneron
Enrollment open: PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (clinicaltrials.gov) - May 18, 2023
P2, N=25, Recruiting, Sponsor: Duke University
Favourable outcomes were obtained despite involving the oldest hitherto reported study cohort for anti-PD-1 antibodies and a significant proportion of CHM patients prone to high risk tumors and an aggressive course otherwise typically excluded from clinical trials. Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial primary completion date, IO biomarker: SiCARIO: Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer (clinicaltrials.gov) - May 16, 2023
P1/2, N=25, Recruiting, Sponsor: Vanderbilt-Ingram Cancer Center
Not yet recruiting --> Recruiting Trial completion date: Oct 2026 --> Feb 2027 | Trial primary completion date: Oct 2025 --> Feb 2026
- || Lynozyfic (linvoseltamab) / Regeneron, Sanofi
Trial completion date, Trial primary completion date: LINKER-MM2: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments (clinicaltrials.gov) - May 16, 2023
P1b, N=317, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Oct 2026 --> Feb 2027 | Trial primary completion date: Oct 2025 --> Feb 2026 Trial completion date: May 2032 --> Aug 2032 | Trial primary completion date: Oct 2026 --> Jan 2027
- MODULE 5: Current Management of Metastatic NSCLC without a Targetable Tumor Mutation (Hilton Chicago, Grand Ballroom ) - May 15, 2023 - Abstract #ASCO2023ASCO_7041;
This event is organized and accredited by Research to Practice and supported through educational grants provided by AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Lilly, Novocure Inc, Regeneron Pharmaceuticals Inc, and Takeda Pharmaceuticals USA Inc. Key factors in the selection of anti-PD-1/PD-L1 monotherapy, combined chemoimmunotherapy or dual immune checkpoint inhibition with or without chemotherapy for patients with newly diagnosed metastatic NSCLC without a targetable tumor mutation Clinical trial database supporting the FDA approvals of pembrolizumab, atezolizumab and cemiplimab administered as monotherapy for the first-line treatment of metastatic NSCLC Major findings from clinical trials evaluating various combinations of pembrolizumab and atezolizumab with chemotherapy as first-line treatment for advanced NSCLC Key results from the Phase III EMPOWER-Lung 3 study of first-line cemiplimab in combination with platinum-based chemotherapy; recent FDA approval and current clinical role Long-term follow-up from the Phase III CheckMate 227 and CheckMate 9LA trials evaluating first-line nivolumab/ipilimumab with and without chemotherapy for metastatic NSCLC; patient selection for these strategies Principal efficacy and safety findings from the Phase III POSEIDON trial evaluating durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy versus chemotherapy alone as first-line therapy for patients with metastatic NSCLC Recent FDA approval of durvalumab/tremelimumab/chemotherapy and current role in clinical practice
- | Libtayo (cemiplimab) / Regeneron
Journal, HEOR, Cost-effectiveness, Cost effectiveness, Metastases: Cost-effectiveness of cemiplimab plus chemotherapy versus chemotherapy for the treatment of advanced non-small cell lung cancer. (Pubmed Central) - May 14, 2023
The performance of model was mainly determined by the price of cemiplimab, according to a one-way sensitivity analysis. From the third-party payer perspective, cemiplimab combined chemotherapy is unlikely to be a cost-effective option for the treatment of aNSCLC at the WTP threshold of $150,000/QALY in the United States.
- || Libtayo (cemiplimab) / Regeneron, Erivedge (vismodegib) / Roche
Biomarker, Review, Journal, Tumor microenvironment: Review of the Tumor Microenvironment in Basal and Squamous Cell Carcinoma. (Pubmed Central) - May 13, 2023
Understanding the crosstalk that occurs within the tumor microenvironment has led to the development of immunotherapeutic agents, including vismodegib and cemiplimab to treat BCC and SCC, respectively. However, further investigation of the TME will provide the opportunity to discover novel treatment options.
- Libtayo (cemiplimab) / Regeneron, odronextamab (REGN1979) / Regeneron
TRIAL IN PROGRESS: PHASE 1 TRIAL EVALUATING THE SAFETY AND TOLERABILITY OF ODRONEXTAMAB IN COMBINATION WITH CEMIPLIMAB IN RELAPSED/REFRACTORY AGGRESSIVE B-CELL NON-HODGKIN LYMPHOMA () - May 12, 2023 - Abstract #EHA2023EHA_2755;
P2
However, further investigation of the TME will provide the opportunity to discover novel treatment options. This Ph 1 trial is determining the tolerability and preliminary clinical efficacy of odronextamab plus cemiplimab to treat pts with R/R aggressive B-NHL.
- Prevalence of Immune Checkpoint Inhibitor-Related Endocrinopathies in Patients With Cancers (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_859;
With the increasing use of immune checkpoint inhibitors in cancer therapy, there is increased prevalence of endocrinopathies. Periodic hormonal assessment along with close monitoring of new symptoms results in early detection of endocrinopathies as the time of onset varies significantly with the type of ICI agent and the use of single vs combination therapy.
- Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy (clinicaltrials.gov) - May 9, 2023
P1/2, N=30, Suspended, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Periodic hormonal assessment along with close monitoring of new symptoms results in early detection of endocrinopathies as the time of onset varies significantly with the type of ICI agent and the use of single vs combination therapy. Trial completion date: Mar 2024 --> Sep 2027 | Trial primary completion date: Mar 2024 --> Sep 2027
- || REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed: Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - May 9, 2023
P1, N=85, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Mar 2024 --> Sep 2027 | Trial primary completion date: Mar 2024 --> Sep 2027 Recruiting --> Active, not recruiting
- ||| Libtayo (cemiplimab) / Regeneron
P3 data, Journal, HEOR, Patient reported outcomes, Metastases: Quality of life with cemiplimab plus chemotherapy for first-line treatment of advanced non-small cell lung cancer: Patient-reported outcomes from phase 3 EMPOWER-Lung 3. (Pubmed Central) - May 8, 2023
Recruiting --> Active, not recruiting Cemiplimab
- ||| Libtayo (cemiplimab) / Regeneron
T:👉 Faz 3 EMPOWER-Lung 3 çalışmasındaki hastaların bildirdiği şikayet/semptomların sonuçları yayınlandı. * Cemiplimab (PD-1 bloke eden immünoterapi) platin bazlı kemoterapiye eklenmesinin sadece platin bazlı kemoterapiye kıyasla ileri aşama küçük hücreli olmayan akciğer kanseri… https://t.co/LTSc9KytTA (Twitter) - May 7, 2023
- ||| Review, Journal, Adverse events, Checkpoint inhibition: Immune-related adverse events and immune checkpoint inhibitors: a focus on neurotoxicity and clinical management. (Pubmed Central) - May 5, 2023
They should be carefully monitored at least 6 months after the end of treatment. ICIs-related nervous toxicities require a multidisciplinary management, in which neurologists and clinical pharmacologists should participate.
- | Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial: Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 3, 2023
P2, N=34, Not yet recruiting, Sponsor: City of Hope Medical Center
- || Retrospective data, Review: Cardiotoxicity of lung cancer-related immunotherapy versus chemotherapy: a systematic review and network meta-analysis of randomized controlled trials. (Pubmed Central) - May 1, 2023
Therefore, clinicians should consider this evidence when developing an ICI immunotherapy regimen for lung cancer. https://www.crd.york.ac.uk/prospero, identifier CRD42023360931.
- | CP-506 / Convert Pharma
Enrollment open, Monotherapy: Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI (clinicaltrials.gov) - May 1, 2023
P1/2, N=126, Recruiting, Sponsor: Maastricht University
https://www.crd.york.ac.uk/prospero, identifier CRD42023360931. Not yet recruiting --> Recruiting
- |||| Imjudo (tremelimumab) / AstraZeneca, Pfizer, Libtayo (cemiplimab) / Regeneron, Imfinzi (durvalumab) / AstraZeneca
Dr. @JulieBrahmer - IO lung cancer pioneer - brings us up to speed on newer additions to our arsenal like cemiplimab, durvalumab and tremelimumab and some critical studies like INSIGNA, that will help us understand optimal approaches. #OncLiveSOSS (Twitter) - Apr 27, 2023
- Libtayo (cemiplimab) / Regeneron
Cemiplimab in first line treatment for locally advanced and metastatic skin squamous cell carcinoma in Slovenia. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6595;
Cemiplimab has shown meaningful efficacy with DCR of 52 % in patients with laSCC and mSCC in Slovenia. Patients developing irAE had higher response rate.
- Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS
Immune checkpoint inhibitors in cutaneous squamous cell carcinoma: A systematic review of clinical trials. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6593;
ICIs including cemiplimab, pembrolizumab, and nivolumab were effective in the treatment of resectable, LA, and mcSCC. ICIs were effective in the treatment of both R/R and treatment na
- Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Immune checkpoint inhibitors in advanced cutaneous squamous cell carcinoma: Real-world evidence. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6586;
Our BOR was higher than in the published clinical trials, which might reflect the subjective nature of investigator-assessed response or the small sample size assessed. >
- How comparable are outcomes for approved PD-1/PD-L1 checkpoint inhibitors (CPI)? A model-informed drug development approach to answer the question. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6508;
To our knowledge, this is the first such analysis in mNSCLC comparing efficacy and safety across PD-(L)1 based therapies. Results suggest PD-(L)1 CPI have similar treatment outcomes in mNSCLC, and PD-L1 expression may be more impactful on clinical benefit of monotherapy compared to CPI combination with chemotherapy.
- Obesity, dyslipidemia, and diabetes as determinants of response to immune checkpoint inhibitors in non-small cell lung cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6488;
Conversely, dyslipidemia and hyperglycemia were associated with worse OS. This represents an important disconnect within the metabolic milieu governing differential responses to IOs.
- Libtayo (cemiplimab) / Regeneron, Firmagon (degarelix) / Astellas, Ferring
The PRIME-CUT study: A single-arm phase 2 study of ADT with PD-1 blockade and docetaxel in men with metastatic hormone-sensitive prostate cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_5482;
P2
However, PSA kinetics and results from the pre-planned correlative science demonstrate ongoing role for immunotherapeutic approaches in mHSPC. No new safety signals were observed.
- Neoadjuvant immunotherapy in hepatocellular carcinoma: A systematic review and meta-analysis. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_5207;
The addition of TKIs to neoadjuvant ICIs does not appear to affect pathological and safety outcomes. Further studies are needed to identify ICI based regimens to improve pCR rates and validate pathological outcomes in HCC after correlating with recurrence and survival.