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- | Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Immune Checkpoint Inhibitors-Associated Cardiotoxicity. (Pubmed Central) - Mar 11, 2022
Ipilimumab and pembrolizumab use may increase the risk of cardiotoxicity compared to other agents. Avelumab also estimated a highly elevated risk (aHR: 1.92; 95% CI: 0.85-4.34; p = 0.117) compared to nivolumab and other PD-L1 agents, although the estimate did not reach statistical significance, warranting future studies.
- Libtayo (cemiplimab) / Sanofi, Regeneron
Primary analysis of phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma who progressed on or were intolerant to hedgehog inhibitors (Section 36) - Mar 9, 2022 - Abstract #AACR2022AACR_3962;
P2
Avelumab also estimated a highly elevated risk (aHR: 1.92; 95% CI: 0.85-4.34; p = 0.117) compared to nivolumab and other PD-L1 agents, although the estimate did not reach statistical significance, warranting future studies. Cemiplimab provided clinically meaningful antitumor activity, including durable responses, and an acceptable safety profile in patients with mBCC who had progressed on or were intolerant to HHI therapy.
- | Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Journal: Treatment of advanced cutaneous squamous cell carcinoma: a Mohs surgery and dermatologic oncology perspective. (Pubmed Central) - Mar 8, 2022
The field of immunotherapeutics continues to expand with adjuvant, neoadjuvant and intralesional studies currently in progress. Herein, the authors discuss their approach for the treatment of advanced cutaneous squamous cell carcinoma from the perspective of a Mohs surgeon and a dermatologic oncologist.
- Libtayo (cemiplimab) / Sanofi, Regeneron
Budget Impact (BI) of First-Line (1L) Cemiplimab Monotherapy for Advanced Non-Small Cell Lung Cancer (aNSCLC) with Programmed Cell Death-Ligand 1 (PD-L1) ≥50% in a Large US Health Plan: An Updated Analysis (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_1103;
Cemiplimab uptake, projected to increase from 1% (Year 1) to 6% (Year 2) to 10% (Year 3), was displaced from pembrolizumab monotherapy (100%). Cemiplimab monotherapy is likely associated with US healthcare payer budgetary savings for treatment of 1L aNSCLC with PD-L1≥50%.
- Libtayo (cemiplimab) / Sanofi, Regeneron
The Voice of the Regulator: How FDA Appraises Clinical Outcome Assessments in Supplemental Submissions for Expanded Indications (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_269;
FDA aims to be as transparent as possible in the context of the regulatory-commercial nature of their remit and generally makes information available to the public in a way that is straightforward and reasonable. In the case of supplemental indications, skilled researchers may pursue other avenues, but the information will invariably be incomplete.
- || Libtayo (cemiplimab) / Sanofi, Regeneron
P2 data, Clinical Trial,Phase II, Journal: Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial. (Pubmed Central) - Mar 1, 2022
P2
This report is, to our knowledge, the largest clinical trial of a neoadjuvant anti-PD-1 monotherapy reported to date in hepatocellular carcinoma. The observed pathological responses to cemiplimab in this cohort support the design of larger trials to identify the optimal treatment duration and definitively establish the clinical benefit of preoperative PD-1 blockade in patients with hepatocellular carcinoma.
- | pegenzileukin (SAR444245) / Sanofi
Trial completion date: A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov) - Feb 28, 2022
P1/2, N=80, Recruiting, Sponsor: Sanofi
The observed pathological responses to cemiplimab in this cohort support the design of larger trials to identify the optimal treatment duration and definitively establish the clinical benefit of preoperative PD-1 blockade in patients with hepatocellular carcinoma. Trial completion date: Aug 2024 --> Jun 2023
- | E-602 / Palleon Pharma
New P1/2 trial: Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01) (clinicaltrials.gov) - Feb 28, 2022
P1/2, N=267, Recruiting, Sponsor: Palleon Pharmaceuticals, Inc.
- || Libtayo (cemiplimab-rwlc) / Regeneron
New P1 trial: A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab (clinicaltrials.gov) - Feb 28, 2022
P1, N=44, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron
"Cemiplimab (PD-1 inhibitor) Induced Rash and Mucositis" - Karina Rotella, Shradha Agarwal & Gary Stadtmauer tomorrow @ 9:45am #AAAAI22 @IcahnMountSinai @DOMSinaiNYC (Twitter) - Feb 25, 2022
- | Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Attitudes among dermatologists regarding non-melanoma skin cancer treatment options. (Pubmed Central) - Feb 25, 2022
However, for locally advanced and metastatic forms of basal and squamous cell carcinoma, Hedgehog Pathway Inhibitors and anti- Programmed cell death protein antibody treatment, respectively, were used in line with the newest evolution of therapies regarding this topic. Considering the importance of skin cancers and its progressive increase in incidence, it is crucial to improve the knowledge of different therapeutic approaches among dermatologists.
- || Libtayo (cemiplimab) / Sanofi, Regeneron
.@AnaOaknin: “Cemiplimab es el primer tratamiento inmunitario que demuestra una mejora en la supervivencia global en pacientes cuya enfermedad había progresado con el tratamiento de primera línea con quimioterapia con platino”. En @iSanidad https://t.co/vVcZ9yCM8k (Twitter) - Feb 25, 2022
- | Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays. (Pubmed Central) - Feb 24, 2022
However, once steady state is achieved for the new therapy, prior biologics would likely not be detected. Cross-reactivity and interference in immunoassays from previous treatment with class-specific biotherapeutic(s) pose significant bioanalytical challenges, especially in immuno-oncology.
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Survival with Cemiplimab in Recurrent Cervical Cancer. An impressive phase 3 trial showing that the addition of this PDL1 antibody to chemotherapy was much better than just chemotherapy alone except of course in those whose PDL1 was less than 1% https://t.co/aYZH3i19wm (Twitter) - Feb 24, 2022
- ||| ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment change, Trial primary completion date: R4018-ONC-1721: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - Feb 23, 2022
P1/2, N=554, Recruiting, Sponsor: Regeneron Pharmaceuticals
Cross-reactivity and interference in immunoassays from previous treatment with class-specific biotherapeutic(s) pose significant bioanalytical challenges, especially in immuno-oncology. N=404 --> 554 | Trial primary completion date: Dec 2023 --> Jul 2024
- || Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Tumor Mutational Burden, IO biomarker: Immunotherapy for Non-melanoma Skin Cancer. (Pubmed Central) - Feb 22, 2022
Immunotherapy is emerging as the standard of care for several advanced NMSCs not amenable to surgery and radiation. Ongoing evaluation of the clinical trial landscape is needed to optimize enrollment and ensure continued innovation.
- |||| SAR439459 / Sanofi
Trial termination, Monotherapy: A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 22, 2022
P1, N=161, Terminated, Sponsor: Sanofi
Ongoing evaluation of the clinical trial landscape is needed to optimize enrollment and ensure continued innovation. Active, not recruiting --> Terminated
- ||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, Enrollment change, Trial primary completion date: Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC (clinicaltrials.gov) - Feb 21, 2022
P2, N=3, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Active, not recruiting --> Terminated Recruiting --> Active, not recruiting | N=27 --> 3 | Trial primary completion date: Jan 2022 --> Nov 2022
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a sing... https://t.co/LZGklpMme7. Congratulations to our very own @DieHCCDie @BachirTaouli for contributing to this amazing work to advance the clinical care for liver cancer pts. 👏🏼🙌 (Twitter) - Feb 20, 2022
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal, HEOR, PD(L)-1 Biomarker: Cost-Effectiveness of Cemiplimab Versus Standard of Care in the United States for First-Line Treatment of Advanced Non-small Cell Lung Cancer With Programmed Death-Ligand 1 Expression ≥50. (Pubmed Central) - Feb 19, 2022
Recruiting --> Active, not recruiting | N=27 --> 3 | Trial primary completion date: Jan 2022 --> Nov 2022 Findings suggest that cemiplimab, versus pembrolizumab or versus chemotherapy, is a cost-effective first-line treatment option for advanced non-small cell lung cancer with programmed death-ligand 1 expression ≥50%.
- | Libtayo (cemiplimab) / Regeneron
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: Survival with Cemiplimab in Recurrent Cervical Cancer. (Pubmed Central) - Feb 19, 2022
P3
Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. (Funded by Regeneron Pharmaceuticals and Sanofi; EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 ClinicalTrials.gov number, NCT03257267.).
- Libtayo (cemiplimab) / Sanofi, Regeneron
Patient-reported outcomes (PROs) with first-line (1L) cemiplimab in patients with locally advanced non-small cell lung cancer (laNSCLC): EMPOWER-Lung 1 subpopulation ([VIRTUAL]) - Feb 19, 2022 - Abstract #ELCC2022ELCC_375;
P3
Conclusions In this post hoc analysis of patients with laNSCLC and PD-L1 ≥50%, cemiplimab resulted in significant favourable overall change from BL in GHS/QoL and important cancer-related and lung cancer–specific symptoms versus chemo. PRO results further support the favourable benefit-risk profile of 1L cemiplimab versus chemo in laNSCLC with PD-L1 ≥50%.
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Update on Management Recommendations for Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Feb 16, 2022
The anti-PD-1 agent cemiplimab is currently the only FDA/EMA-approved first-line therapy for patients with locally advanced or metastatic cSCC who are not candidates for curative surgery or RT. Given the likelihood of recurrence and the increased risk of developing multiple cSCC, close follow-up should be performed during the first years of treatment and continued long-term surveillance is warranted.
- ||| We are witnessing the greatest expansion of Rx options for rec CxCA in history. Another option now in addition to Tivdak, pembro, & taxol/carbo/bev +/- pembro. Amazing! Survival with Cemiplimab in Recurrent Cervical Cancer | NEJM https://t.co/csm87k1KPF (Twitter) - Feb 16, 2022
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal, Checkpoint inhibition: Immune checkpoint inhibitors for advanced or metastatic basal cell carcinoma: how much evidence do we need? (Pubmed Central) - Feb 15, 2022
Immune checkpoint inhibitors have been assessed in melanoma and other cutaneous tumors, and very recently an anti-PD1 was approved for advanced BCC. In this paper, available data are reviewed on experimental and preclinical studies evaluating immunotherapy in BCC, as well as on the clinical evidence supporting the efficacy and safety of immune checkpoint inhibitors for advanced or metastatic BCC based on case reports, case series and clinical trials.
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
🗞 Published in @NEJM, results of the phase III EMPOWER trial #GOG #ENGOT, co-authored by VHIO’s @AnaOaknin, show improved survival with PD-1 blocking antibody cemiplimab in recurrent #cervicalcancer. https://t.co/NcKTdrm27x (Twitter) - Feb 14, 2022
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
🔥 @ACCinTouch #cardioonc mtg by @AnaBaracCardio & #BonnieKy! 👏 to top 10 🏆 abstracts! @UCLAHealth IM res @kaustav_shah 🎁 a case of ICI myocarditis —SOB 2 days after Cemiplimab 4 SCC —❤️ block w/ VF😳 —EPS ➡️😱 high HV (200 msec!) —Rechallenged after PPM w/ 👍 clin response! (Twitter) - Feb 13, 2022
- |||| Tyvyt (sintilimab) / Eli Lilly, Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Clinical, FDA event: Historically it hasn't, but Lilly wasn't proposing a "disruptive" price for sintilimab out of altruism. They realized this was their only play & determined it was worth it. Cemiplimab got FDA approval for high PD-L1, priced like pembro, & has had approximately 0 pts receive it. (Twitter) - Feb 13, 2022
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Pricing: As @PatelOncology & I have been discussing on another thread, I was disappointed that @US_FDA shot down path to incremental benefit of price reduction for comparable but not better IO. Remove $$ variable & these agents/trials add nothing (including cemiplimab for high PD-L1). (Twitter) - Feb 11, 2022
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
FDA event: I would have voted against, based on the specifics here. What I object to is the categorical dismissal of concept that price can or ever should be a factor. Price is why cemiplimab at cost = pembro is a useless FDA approval, but it would be vy welcome if priced at 60% of pembro. (Twitter) - Feb 11, 2022
- || Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), balstilimab (AGEN2034) / Agenus, Recepta
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Current and emerging immunotherapies for recurrent cervical cancer. (Pubmed Central) - Feb 11, 2022
This review discusses the KEYNOTE-158 and KEYNOTE-826 trials of pembrolizumab, along with the EMPOWER CERVICAL 1 (R2810-ONC-1676/GOG 3016/ENGOT cx9) trial of cemiplimab and a phase 3 trial of balstilimab in cervical cancer. It also discusses the rationale for the use of immunotherapy in the cervical cancer setting, the mechanisms of action of available and currently studied immunotherapies, biomarkers for predicting and assessing response to treatment, and mechanisms of secondary tumoral escape or resistance to immunotherapy.
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Wait till you see how libtayo got approved (Twitter) - Feb 10, 2022
- ||| Tyvyt (sintilimab) / Eli Lilly, Libtayo (cemiplimab) / Sanofi, Regeneron, Cejemly (sugemalimab) / CStone Pharma, EQRx
IMO, many oncs would appreciate @US_FDA directly considering cost when making decisions. Sintilimab or sugemalimab at significantly lower cost vs. other IOs offers real incremental benefit. OTOH, approving cemiplimab as 3rd agent vs high PD-L1 NSCLC & at same price is useless. (Twitter) - Feb 9, 2022
- || Tyvyt (sintilimab) / Eli Lilly, Libtayo (cemiplimab) / Sanofi, Regeneron
Looking at the sintilimab adcom briefing docs, do you think the FDA will withdraw the 1L NSCLC label for Libtayo? $LLY $SNY $REGN (Twitter) - Feb 8, 2022
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Clinical, FDA event: And yet Libtayo got FDA approval for 1L NSCLC based on a trial where control patients couldn't get Keytruda (Twitter) - Feb 8, 2022
- Libtayo (cemiplimab) / Sanofi, Regeneron
IMMUNE RESPONSES FOLLOWING ANTI-PD-1 MONOCLONAL ANTIBODY INFUSION IN PERSONS WITH HIV ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_833;
We evaluated multiple immunologic parameters following infusion of cemiplimab, an anti-PD1 monoclonal antibody, in ART-suppressed persons with HIV (PWH) in ACTG A5370...The benefits of this therapeutic strategy for HIV remission should be weighed against the potential for irAE. ?
- | Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Vaccine (VSV-hIFN?-NIS) with or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Feb 7, 2022
P1, N=65, Recruiting, Sponsor: Mayo Clinic
? Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- || ASP8374 / Astellas
Enrollment open: ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - Feb 6, 2022
P1, N=24, Recruiting, Sponsor: Dana-Farber Cancer Institute
Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022 Not yet recruiting --> Recruiting
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
Immunotherapy Response in Cutaneous Squamous Cell Carcinoma Patients With Cranial Nerve Involvement (JW Marriott Phoenix Desert Ridge Resort and Spa - Grand Canyon 6-8) - Feb 6, 2022 - Abstract #MHNCS2022MHNCS_223;
All patients treated with IO alone demonstrated a clinical response, indicating IO can be an effective monotherapy. Given the challenges of RT with extensive perineural invasion, RT can be reserved in the event of local failure after IO.
- Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono
Budget Impact of Keytruda for the Treatment of Patients With Recurrent or Metastatic (R/M) and Locally Advanced (LA) Cutaneous Squamous Cell Carcinoma (cSCC) in the United States (JW Marriott Phoenix Desert Ridge Resort and Spa - Grand Canyon 6-8) - Feb 6, 2022 - Abstract #MHNCS2022MHNCS_169;
Comparators included commonly used systemic therapies (cemiplimab-rwlc, cetuximab, cisplatin + paclitaxel and cisplatin + 5-FU)...Table 1: Three year budget impact ($m) of KEYTRUDA in cSCC Conclusion : The introduction of KEYTRUDA for R/M and LA cSCC patients in a hypothetical plan of 1 million members is projected to lead to budgetary savings of 7% over three years. Results are most sensitive to assumed time on treatment.
- | Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Journal: Immunotherapy to Avoid Orbital Exenteration in Patients With Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Feb 5, 2022
The management of CSCC can be complex and requires the input of a multidisciplinary team. Immunotherapy to avoid or reduce the extent of morbid definitive surgery is an emerging treatment option.
- Libtayo (cemiplimab) / Sanofi, Regeneron
Cemiplimab (PD-1 inhibitor) Induced Rash and Mucositis () - Feb 4, 2022 - Abstract #AAAAI2022AAAAI_1483;
Although similar mucocutaneous symptoms have been reported in the literature with other immune-checkpoint inhibitors, this is the first reported case of cemiplimab-induced rash and mucositis. This case illustrates the importance of timely recognition of potential mucocutaneous symptoms associated with immune checkpoint inhibitors such as cemiplimab, in order to avoid delays in diagnosis and initiate appropriate treatment.
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Review, Journal: Management of periocular cutaneous squamous cell carcinoma with perineural invasion: a case series and literature review. (Pubmed Central) - Feb 3, 2022
With novel therapies and new treatment patterns, optimal combinations and intensities of individual modalities require further elucidation. The oculofacial plastic surgeon plays a pivotal role - in diagnosis, coordination of interdisciplinary management, thoughtful surgical reconstruction, and postoperative surveillance.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Trial initiation date: CEMangio: Cemiplimab for Secondary Angiosarcomas (clinicaltrials.gov) - Feb 3, 2022
P2, N=18, Recruiting, Sponsor: Radboud University
The oculofacial plastic surgeon plays a pivotal role - in diagnosis, coordination of interdisciplinary management, thoughtful surgical reconstruction, and postoperative surveillance. Not yet recruiting --> Recruiting | Initiation date: Oct 2021 --> Jan 2022
- || Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, Checkpoint inhibition, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Immune checkpoint inhibitors for brain metastases in non-small-cell lung cancer: from rationale to clinical application. (Pubmed Central) - Feb 2, 2022
In addition, clinical data on NSCLC BM were inadequate. Here, we review the theoretical basis and clinical data for the application of ICIs in the therapy of NSCLC BM.
- || Review, Journal: Investigative Landscape in Advanced Non-Melanoma Skin Cancers. (Pubmed Central) - Feb 1, 2022
Current clinical trials are continuing to evaluate the use of immune checkpoint inhibitors and hedgehog pathway inhibitors. There is further need for ongoing research and development of new therapies in both malignancies.
- || Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date, IO biomarker: LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov) - Feb 1, 2022
P1/2, N=38, Recruiting, Sponsor: University Medical Center Groningen
There is further need for ongoing research and development of new therapies in both malignancies. Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Jan 2024 --> Sep 2024
- || ASP8374 / Astellas
Enrollment change: ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - Feb 1, 2022
P1, N=24, Not yet recruiting, Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Jan 2024 --> Sep 2024 N=65 --> 24
- ||| Sarclisa (isatuximab-irfc) / Sanofi
Enrollment change, Trial primary completion date: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Jan 31, 2022
P1/2, N=58, Active, not recruiting, Sponsor: Sanofi
N=65 --> 24 N=130 --> 58 | Trial primary completion date: Feb 2021 --> Nov 2022
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, PK/PD data, Journal: Population pharmacokinetic characteristics of cemiplimab in patients with advanced malignancies. (Pubmed Central) - Jan 29, 2022
P1, P2
Similarity in observed cemiplimab exposure at the fixed 350 mg Q3W and the weight-based 3 mg/kg Q2W dose regimens confirmed this fixed dose selection. A robust PopPK model was developed to describe cemiplimab concentrations and supported use of the fixed 350 mg Q3W IV dose regimen.