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- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal, Checkpoint inhibition, Immunomodulating, Metastases: The Immunomodulatory Potential of Concurrent High-Dose Radiotherapy and Immune Checkpoint Inhibitor Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma: Initial Results. (Pubmed Central) - Jun 27, 2024
Despite the retrospective nature of this study and small sample size, our experience highlights the ability of concomitant radiotherapy and cemiplimab to promote an early objective response in patients with advanced CSCC. Moreover, in our population, the clinical benefits were also related to a longer progression-free survival, without any safety alert reported.
- ||| 27T51 / Regeneron
New P1 trial, CAR T-Cell Therapy, Immune cell: A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers (clinicaltrials.gov) - Jun 21, 2024
P1, N=90, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- || Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
P1 data, Journal, Combination therapy, Metastases: Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma. (Pubmed Central) - Jun 20, 2024
Moreover, in our population, the clinical benefits were also related to a longer progression-free survival, without any safety alert reported. The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, including those with previous anti-PD-1 therapy in the adjuvant, but not advanced, setting.
- || Review, Journal, HEOR, Checkpoint inhibition, Real-world evidence, Real-world: Immune checkpoint inhibitors-associated diabetes and ketoacidosis were found in FAERS: A Real-World Evidence Database Study. (Pubmed Central) - Jun 15, 2024
The study reveals the risk and characteristics of diabetes and ketoacidosis associated with ICIs, which may provide evidence for post-marketing evaluation. Careful consideration should be given to the possibility of an increased risk of diabetes and ketoacidosis after using ICIs, and careful monitoring for diabetes and ketoacidosis is recommended.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Biomarker, Trial completion date, Trial primary completion date, Metastases: BIOSELECT: BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (clinicaltrials.gov) - Jun 14, 2024
P1/2, N=16, Not yet recruiting, Sponsor: AHS Cancer Control Alberta
Careful consideration should be given to the possibility of an increased risk of diabetes and ketoacidosis after using ICIs, and careful monitoring for diabetes and ketoacidosis is recommended. Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Feb 2025
- || Libtayo (cemiplimab-rwlc) / Regeneron
Clinical data, Retrospective data, Journal, Metastases: Impact of cemiplimab treatment duration on clinical outcomes in advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Jun 8, 2024
Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Feb 2024 --> Feb 2025 Among the 22 STS patients, 12 received cemiplimab for less than 12
- || Libtayo (cemiplimab-rwlc) / Regeneron
Biomarker, Clinical data, Journal: Clinical Outcomes and Prognostic Factors in Patients With Penile Carcinoma: A Sub-Analysis From Meet-URO 23 (I-RARE) Registry Study. (Pubmed Central) - Jun 6, 2024
In our registry study, PSCC is confirmed to be an aggressive disease. Poor ECOG PS, presence of lymph node metastases, and higher age at diagnosis appear to be associated with worse survival outcomes.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal: Spontaneous regression of aggressive cutaneous squamous cell carcinoma. (Pubmed Central) - Jun 6, 2024
Poor ECOG PS, presence of lymph node metastases, and higher age at diagnosis appear to be associated with worse survival outcomes. No abstract available
- | Libtayo (cemiplimab-rwlc) / Regeneron
Biomarker, Journal, PD(L)-1 Biomarker, Metastases: Advanced cutaneous squamous cell carcinoma: Impact of age on the safety and efficacy of cemiplimab and the prognostic significance of blood biomarkers. (Pubmed Central) - Jun 5, 2024
Despite a higher incidence of primary progression and shorter OS in the oldest cohort, cemiplimab yielded robust objective responses regardless of age. Higher pre-treatment NLR was associated with shorter survival and the cut-point identified requires further study.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal, PD(L)-1 Biomarker, Metastases: Good clinical response to cemiplimab in a young patient with locally advanced cutaneous squamous cell carcinoma on preexisting recessive dystrophic epidermolysis bullosa. (Pubmed Central) - May 29, 2024
During follow-up, the patient had a notable clinical response with no auto-immune adverse reactions. This shows that cemiplimab has a good safety profile for cSCC in patients with RDEB and is a valuable therapy option.
- || Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma: a GRADE approach for evidence evaluation and recommendations by the Italian Association of Medical Oncology. (Pubmed Central) - May 26, 2024
These guidelines, developed by the Italian Association of Medical Oncologists (AIOM) using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, aim to guide clinicians in diagnosing, treating, and monitoring patients with CSCC, covering key aspects from primitive tumors to advanced stages, selected by a panel of experts selected by AIOM and other national scientific societies. The incorporation of these guidelines into clinical practice is expected to enhance patient care and address the evolving landscape of CSCC management.
- || Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS
Review, Journal, Metastases: Metastatic patterns and treatment options for head and neck cutaneous squamous cell carcinoma (Review). (Pubmed Central) - May 17, 2024
Notably, there is an urgent need to identify patients who may benefit from local or systemic cancer treatments. The treatment of lymph node metastasis presents a therapeutic challenge and requires comprehensive management.
- ||| Clinical, Retrospective data, Journal, Adverse events, Checkpoint inhibition: Adverse events associated with immune checkpoint inhibitors in non-small cell lung cancer: a safety analysis of clinical trials and FDA pharmacovigilance system. (Pubmed Central) - May 15, 2024
As far as any or grades 3-5 irAEs are concerned, atezolizumab plus bevacizumab plus chemotherapy is considered the most safety option...These findings revealed that ICIs differed in their safety profile. ICI treatment strategies can be improved and preventive methods can be developed for NSCLC patients based on our results.
- || Libtayo (cemiplimab-rwlc) / Regeneron
Review, Journal: Efficacy and Safety of Cemiplimab for the Management of Non-Melanoma Skin Cancer: A Drug Safety Evaluation. (Pubmed Central) - May 11, 2024
Moreover, the collaboration among specialists will allow them to best manage the TEAEs, reducing the risk of treatment suspension or discontinuation. Certainly, ongoing studies and more and more emerging real-world evidence, will allow us to better characterize the role of cemiplimab for the management of advanced non-melanoma skin cancer.
- | Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Journal, Metastases: Neoadjuvant-Intent Immunotherapy in Advanced, Resectable Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - May 9, 2024
Outside of clinical trials, it is not infrequent for patients to opt out of surgery for regressing tumors. The inclusion of higher-risk patients and preference for nonsurgical treatment are 2 factors that might explain the numerically lower pathologic response rate in this institutional experience.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Journal, Metastases: Long-term survival after anti-PD-1 discontinuation in advanced cutaneous squamous cell carcinoma (cSCC): a proof of concept of benefit of concomitant cemiplimab and radiotherapy. (Pubmed Central) - May 7, 2024
The inclusion of higher-risk patients and preference for nonsurgical treatment are 2 factors that might explain the numerically lower pathologic response rate in this institutional experience. Our study confirms a long-term and persistent effect despite discontinuation of cemiplimab at least up to 2 years later.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Observational data, Journal, Real-world evidence, Real-world, Metastases: Real-world multicentre observational study of effectiveness and toxicity in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab. (Pubmed Central) - May 7, 2024
Our study confirms a long-term and persistent effect despite discontinuation of cemiplimab at least up to 2 years later. No abstract available
- ||| Journal, Adverse events: Endocrine system-related adverse events associated with PD-1/PD-L1 inhibitors: data mining from the FDA adverse event reporting system. (Pubmed Central) - May 7, 2024
There was a lengthy interval between the use of PD-1/PD-L1 inhibitors and endocrine system-related AEs, but the outcome was serious. Special attention should be given to endocrine system-related AEs when using pembrolizumab, nivolumab, or durvalumab.
- ||| Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
FDA event, Journal, Adverse events, Real-world evidence, Real-world: Beyond the Label: Real-World Side Effects Experienced With FDA-Approved Drugs for Non-Melanoma Skin Cancers. (Pubmed Central) - May 6, 2024
Logistic regression analysis showed males on vismodegib for BCC having greater odds of experiencing muscle spasms (aOR 1.33, P<0.001) and ageusia (aOR 1.34, P<0.001) versus females, who were more likely to exhibit alopecia (aOR 1.82, P<0.001) and nausea (aOR 1.96, P<0.001)...Patients taking cemiplimab-rwlc for BCC compared to SCC were more likely to experience disease progression (aOR 10.98, P=0.02)...2024;23(5):301-305. doi:10.36849/JDD.7968.
- || Libtayo (cemiplimab-rwlc) / Regeneron
Clinical, Journal, Metastases: Real-life efficacy and safety of cemiplimab in advanced cervical cancer from a nominal use program in Italy: The MITO 44 study. (Pubmed Central) - May 2, 2024
doi:10.36849/JDD.7968. This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open: Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 1, 2024
P2, N=34, Recruiting, Sponsor: City of Hope Medical Center
This study confirms the feasibility and the replicability of the cemiplimab nominal use in advanced CC, in a real-world practice in Italy. Not yet recruiting --> Recruiting
- ||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: R3767-ONC-1613: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers (clinicaltrials.gov) - May 1, 2024
P1, N=333, Completed, Sponsor: Regeneron Pharmaceuticals
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
- Libtayo (cemiplimab-rwlc) / Regeneron
Cemiplimab in the treatment of basal cell carcinoma (e-Poster Hall) - Apr 28, 2024 - Abstract #EADVSp2024EADV_Sp_290;
- |||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial primary completion date, Metastases: EMPOWER-Lung 3: Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer (clinicaltrials.gov) - Apr 25, 2024
P3, N=790, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024 Trial primary completion date: Jul 2023 --> Feb 2025
- |||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
New P2 trial, Combination therapy: Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) (clinicaltrials.gov) - Apr 25, 2024
P2, N=140, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Libtayo (cemiplimab-rwlc) / Regeneron
Immunotherapy for local/regional control of locally advanced orbital and periocular squamous cell carcinoma. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6665;
IO either as single drug or in combination with chemotherapy has a fairly high response rate in patients with ocular adnexal, conjunctival or orbital SCC and in patients with periocular SCC with perineural spread in the orbit and skull base. Future prospective trails using IO for orbital and ocular adnexal SCC should be planned and should aim to correlate molecular data such as TMB with response.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
Response rate with cetuximab used less than 3 months after immunotherapy (IO) for recurrent/metastatic head and neck squamous cell carcinomas (R/M HNSCC) compared to larger delay. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5676;
When cetuximab is started early after IO the benefit in terms of ORR of chemo is weak whereas it appears important later than 3 months. This difference in ORR is not clearly associated with a trend in FPS and OS.
- Immune checkpoint inhibitor-related reproductive adverse effects: A pharmacovigilance analysis based on the FAERS database. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5613;
Additional therapies could change the risk of irRAEs. Despite the current lack of high-quality clinical data on this topic, it is reasonable to inform patients about the plausible risk of irRAEs.
- Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
PD-1 checkpoint inhibitors related immune-mediated hepatitis in colon cancer: A systematic review and meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5596;
This would also provide insight for clinical providers to make informed decisions regarding treatment selection. Toxicities are noted to be under-reported; hence we urge clinicians to report such immune toxicities.
- Libtayo (cemiplimab-rwlc) / Regeneron, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
Correlation of distinct circulating cytokine/chemokine profiles with clinical benefits of Pexa-Vec (thymidine kinase-deactivated vaccinia virus plus GM-CSF) and cemiplimab (REGN2810; anti-PD-1) in metastatic or unresectable renal cell carcinoma (mRCC). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5525;
Toxicities are noted to be under-reported; hence we urge clinicians to report such immune toxicities. Our findings suggest the potential utility of plasma cytokine and chemokine profiles in clinical benefits of mRCC patient to the combination of Pexa-Vec and cemiplimab, thereby aiding in future personalized treatment approaches.
- PRE-ISPY phase I/Ib oncology platform program (PRE-I-SPY-P1). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5186;
P1
2 or other phase 2/3 trials. The first patient was enrolled on 2/1/2023.
- Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Ulcer-related cutaneous squamous cell carcinoma: New kid on the block. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4934;
This study suggests immunotherapy is less beneficial in ulcer-related SCC. More work is needed to verify our findings and explore other treatment options including chemoimmunotherapy.
- Libtayo (cemiplimab-rwlc) / Regeneron, Aphexda (motixafortide) / BioLineRx, Gloria Pharma
CheMo4METPANC: A randomized phase 2 study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) compared to chemotherapy alone in metastatic treatment-na (Hall A; Poster Bd #: 174a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3937;
P2
Exploratory studies include interrogation of the TME using quantitative multiplex immunofluorescence and single-cell RNA sequencing. The randomized phase 2 trial is open to enrollment and one patient has been randomized as of 1/29/2024.
- Libtayo (cemiplimab-rwlc) / Regeneron, ISA101 / ISA Pharma
Results of a randomized, double-blind, placebo-controlled, phase 2 study (OpcemISA) of the combination of ISA101b and cemiplimab versus cemiplimab for recurrent/metastatic (R/M) HPV16-positive oropharyngeal cancer (OPC). (S100a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3594;
P2
Median OS was better in patients with CPS ?20 who completed a full course of ISA101b. In contrast, patients with lower CPS did not benefit.
- Libtayo (cemiplimab-rwlc) / Regeneron
Can TTMV clearance predict recurrence in HPV HNSCC? (Hall A; Poster Bd #: 382) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3517;
P1
3/11 (27%) with persistently elevated TTMV after cycle 1 relapsed as of this time point. This small study was not large enough to be practice-changing.
- Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
A phase 1 study of fianlimab (anti (Hall A; Poster Bd #: 341) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3489;
P1
This small study was not large enough to be practice-changing. Fianlimab + cemiplimab in pts with HNSCC showed signs of clinical activity with durable responses among pts with anti
- Libtayo (cemiplimab-rwlc) / Regeneron, REGN7075 / Regeneron
A phase 1/2 study of REGN7075 in combination with cemiplimab (cemi) in patients (pts) with advanced solid tumors: Efficacy and safety results. (Hall D2) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3116;
P1/2
REGN7075 is one of the first immune therapies to demonstrate clinical activity in pts with MSS CRC (including a pt with liver metastases), and dose escalation was completed through 900 mg with an acceptable safety profile and no DLTs. One pt experienced Grade 1 CRS, demonstrating differentiation from CD28 superagonists and CD3-targeting bsAbs.
- BDC-3042 / Bolt Biotherap
A phase 1/2 study of BDC-3042, a novel dectin-2 agonistic antibody, in patients with advanced cancers. (Hall A; Poster Bd #: 161a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3093;
P1/2
J Immunother Cancer. 2021.
- Libtayo (cemiplimab-rwlc) / Regeneron, ONM-501 / OncoNano Medicine
A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas. (Hall A; Poster Bd #: 160a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3092;
P1
Secondary endpoints include characterization of pharmacokinetics and pharmacodynamics, as well as initial efficacy based on RECIST evaluation criteria. Enrollment began in November 2023.
- REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
A phase 1 study of REGN6569, a GITR mAb, in combination with cemiplimab in patients (pts) with advanced solid tumor malignancies: Initial dose-escalation results. (Hall A; Poster Bd #: 129) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3051;
P1
In this dose-escalation study, REGN6569 was administered up to 1200 mg (DL5) in combination with cemiplimab with one dose-limiting toxicity. The study has progressed to dose-expansion cohorts in anti
- SNS-101 / Sensei Biotherap, Libtayo (cemiplimab-rwlc) / Regeneron
Initial results from a first-in-human phase 1 study of SNS-101 (pH-selective anti-VISTA antibody) alone or in combination with cemiplimab in patients with advanced solid tumors. (Hall A; Poster Bd #: 79) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3001;
P1/2
Both mono and combo therapy have been generally well tolerated. Early signs of clinical activity were observed in both the acquired and primary PD-1 resistant tumor settings.
- Direct oral anticoagulant versus low molecular weight heparin for venous thromboembolism in patients receiving immune checkpoint inhibitors. (Hall A; Poster Bd #: 256) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2874;
DOACs were associated with a similar risk for subsequent VTE events but a lower risk of intracranial bleeding as well as an improvement in mortality compared to LMWHs among ICI-treated patients with a diagnosis of VTE. Prospective trials are needed to validate these findings.
- ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
A phase 1/2 study of ubamatamab (REGN4018), a MUC16 (Hall A; Poster Bd #: 497b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1944;
P1/2
Exploratory objectives include clinical correlation with serum CA-125, MUC16 IHC, and immune markers. The study is currently enrolling to these OC and EC expansion cohorts.
- Libtayo (cemiplimab-rwlc) / Regeneron, ISA101 / ISA Pharma
Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer. (Hall A; Poster Bd #: 393) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1836;
P2
The study is currently enrolling to these OC and EC expansion cohorts. Results from this phase 2 study of cemiplimab + ISA101b in patients with recurrent HPV16 cervical cancer show clinical benefit, especially in patients with high PD-L1 expression, and no unexpected safety signals, supporting further research.
- Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
A phase 2/3 study of fianlimab plus cemiplimab versus cemiplimab in patients with advanced non-small cell lung cancer with tumors expressing PD-L1 ?50%. (Hall A; Poster Bd #: 519b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1536;
P2/3
Secondary endpoints are safety, ORR, DCR, TTR, DOR, and PFS, per BICR and investigator assessment, patient-reported outcomes, pharmacokinetics, and immunogenicity. This study is open for enrollment along with a second study of fianlimab + cemiplimab + chemotherapy in aNSCLC.
- Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
A phase 2/3 study of fianlimab, cemiplimab, plus chemotherapy versus cemiplimab plus chemotherapy in first-line treatment of advanced non-small cell lung cancer. (Hall A; Poster Bd #: 518a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1533;
P1, P2/3
The secondary endpoints include efficacy (ORR, disease control rate, time to tumor response, duration of response, progression-free survival, and overall survival), safety and tolerability, immunogenicity (anti-drug antibodies and neutralizing antibodies against fianlimab or cemiplimab in serum), patient-reported outcomes, and pharmacokinetics. This study and a parallel study of fianlimab + cemiplimab in patients with aNSCLC with tumors expressing PD-L1 ?50% (NCT05785767) are currently open for enrollment.
- Comparing rates of immune checkpoint inhibitor toxicity in different treatment settings (neoadjuvant, adjuvant, and palliative) in non-small cell lung cancer (NSCLC): A meta-analysis of phase III clinical trials. (Hall A; Poster Bd #: 509) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1518;
A neoadjuvant-only approach is associated with the lowest rates of irAEs and this may be due to the lower number of cycles received. These findings have implications for individual patient treatment decisions and support the use of neoadjuvant immunotherapy in NSCLC.
- 6-thio-2?-Deoxyguanosine (THIO) / MAIA Biotech, Libtayo (cemiplimab-rwlc) / Regeneron
A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Updated results. (Hall A; Poster Bd #: 465) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1476;
P2
Based on safety and promising efficacy, the 180 mg dose was selected for further development. Enrollment is ongoing and is expected to be completed in Feb-2024.
- Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial. (Hall A; Poster Bd #: 176) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1312;
P2
No correlation was observed with age; correlation of AI with response predictive subtype and other clinicopathologic features is ongoing and will be presented. Given the high incidence of AI in EBC, close monitoring in the peri/postoperative setting and education of pts and providers is critical, as risk persists even after completion of tx.
- Trends in prices of checkpoint inhibitors in the US, 2016-2023. (Hall A; Poster Bd #: 270) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1007;
Competition among these brand-name cancer drugs did not meaningfully affect prices. Regulators should investigate why price competition has not emerged, and policymakers should grant more opportunities to negotiate lower prices for patients and the health care system, as is being rolled out this year in Medicare following passage of the Inflation Reduction Act.