- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Biomarker, Review, Journal, PD(L)-1 Biomarker, IO Biomarker: Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Nov 27, 2019
Over time, immunotherapy is likely to be the standard of care for immune-sensitive tumors. There are many challenges that the field faces, including the identification of reliable biomarkers to better predict response, decreasing toxicity, and the potential treatment of organ transplant patients.
- |||||||||| SAR439459 / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: 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) - Nov 27, 2019
P1, N=225, Recruiting,
There are many challenges that the field faces, including the identification of reliable biomarkers to better predict response, decreasing toxicity, and the potential treatment of organ transplant patients. Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Dec 2021
- |||||||||| Libtayo (cemiplimab) / Regeneron
Biomarker, Trial completion date, PD(L)-1 Biomarker, IO biomarker, Immunomodulating, Biopsy: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1) (clinicaltrials.gov) - Nov 15, 2019
P1, N=47, Active, not recruiting,
Trial completion date: Sep 2022 --> Dec 2022 | Trial primary completion date: Sep 2021 --> Dec 2021 Trial completion date: Oct 2019 --> Mar 2020
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Yervoy (ipilimumab) / Ono Pharma, BMS
Enrollment change, Trial completion date, Trial withdrawal, Surgery, Metastases: Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer (clinicaltrials.gov) - Nov 15, 2019
P1, N=0, Withdrawn,
Trial completion date: Nov 2020 --> Oct 2021 | Trial primary completion date: Nov 2020 --> Oct 2021 N=24 --> 0 | Trial completion date: Apr 2020 --> Nov 2019 | Recruiting --> Withdrawn
- |||||||||| Hiltonol (poly-ICLC) / Oncovir
Trial completion date, Trial primary completion date: Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 (clinicaltrials.gov) - Nov 4, 2019
P1/2, N=60, Recruiting,
N=24 --> 0 | Trial completion date: Apr 2020 --> Nov 2019 | Recruiting --> Withdrawn Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2020 --> Aug 2021
- |||||||||| SAR439459 / Sanofi
Trial primary completion date, Combination therapy, Monotherapy, Metastases: 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) - Oct 17, 2019
P1, N=225, Recruiting,
Funding: Regeneron Pharmaceutical, Inc. Trial primary completion date: Oct 2020 --> Sep 2021
- |||||||||| Contrary to Expectation: Preserved Renal Function After Using PD-1 Inhibitor Cemiplimab-rwlc in a Kidney Transplant Recipient (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_4687;
He received Thymoglobulin induction and maintenance immunosuppression with Tacrolimus, MMF and Prednisone...Treatment included Mohs procedure, chemotherapy (paclitaxel/carboplatin/cetuximab) for 4 cycles and radiation for 5 months...Subsequently, he was switched from intratumoral 5FU to intratumoral IL2 and started on immunotherapy with Cemiplimab (Libtayo)...However, as our case shows, PD-1 inhibitor Cemiplimab (Libtayo) can be used with preserving allograft function on a Sirolimus-based immunosuppression regimen. More data is needed in to guide clinicians and to appropriately counsel patients regarding the risks and benefits of immunotherapy medications.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Locally advanced and metastatic cutaneous squamous cell carcinoma treated with cemiplimab (Pubmed Central) - Oct 8, 2019
We present a clinical case of a patient with a locally advanced cSCC of the forehead with bone resorption and cervical lymphadenopathies. After failure of multiple surgical interventions and radiotherapies, he responded partially to cemiplimab immunotherapy with a good safety profile.
- |||||||||| MK1169, a peptide unrelated to IL-2, is a potent IL-2Rβγc receptor agonist (Prince George's Exhibition Halls AB) - Oct 2, 2019 - Abstract #SITC2019SITC_977;
Dual pharmacology therapeutics incorporating MK1169 also offer promise for immuno-oncology. To our knowledge, this work is the first demonstration of small peptide agonists of a heterodimeric cytokine receptor.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Adverse events, Checkpoint inhibition: Ocular adverse events with immune checkpoint inhibitors. (Pubmed Central) - Sep 19, 2019
The results of this disproportionality analysis suggest use of ICIs is associated with an increase risk for ocular adverse reactions. Future epidemiologic studies are needed to better quantify these adverse events.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal, PD(L)-1 Biomarker, IO Biomarker: Cemiplimab for the treatment of advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Sep 13, 2019
Recently, it has been recognized that cSCCs are highly mutated tumors with a denoting potential likelihood of response to immune checkpoint blockade. Cemiplimab is an anti-programmed cell death protein 1 (PD-1) antibody recently approved for the treatment of unresectable locally advanced or metastatic cSCC by the U.S. Food and Drug Administration (FDA) and the European Commission with a compelling response rate and an acceptable safety profile.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Biomarker, Trial completion date, PD(L)-1 Biomarker, IO biomarker, Immunomodulating, Metastases, Biopsy: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1) (clinicaltrials.gov) - Aug 15, 2019
P1, N=33, Active, not recruiting,
Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Feb 2020
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial initiation date: CASE: CemiplimAb Survivorship Epidemiology (clinicaltrials.gov) - Aug 7, 2019
P=N/A, N=350, Recruiting,
N=81 --> 130 Initiation date: Mar 2019 --> Jun 2019
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal: Cemiplimab: First Global Approval. (Pubmed Central) - Aug 3, 2019
The drug is being investigated as a treatment for various cancers and in September 2018 received approval in the USA for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This article summarizes the milestones in the development of cemiplimab leading to this first global approval for the treatment of advanced cutaneous squamous cell carcinoma.
- |||||||||| Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019
In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- |||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Jul 26, 2019
P1/2, N=130, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jan 2023 --> May 2023 | Trial primary completion date: Jan 2023 --> May 2023
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal: Molecular Interactions of Antibody Drugs Targeting PD-1, PD-L1, and CTLA-4 in Immuno-Oncology. (Pubmed Central) - Jul 24, 2019
A comprehensive analysis of the interactions of these immune checkpoint blockers can provide a better understanding of their therapeutic mechanisms of action. The accumulation of these structural studies would provide a basis that is essential for the rational design of next-generation therapies in immuno-oncology.
- |||||||||| nezastomig (REGN5678) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors (clinicaltrials.gov) - Jul 18, 2019
P1/2, N=123, Recruiting,
The accumulation of these structural studies would provide a basis that is essential for the rational design of next-generation therapies in immuno-oncology. Not yet recruiting --> Recruiting | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
- |||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (clinicaltrials.gov) - Jul 15, 2019
P1/2, N=109, Active, not recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024 Recruiting --> Active, not recruiting | Trial completion date: Mar 2021 --> Apr 2020 | Trial primary completion date: Mar 2021 --> Apr 2020
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
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) - Jul 11, 2019
P1, N=589, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Mar 2021 --> Apr 2020 | Trial primary completion date: Mar 2021 --> Apr 2020 Trial completion date: Mar 2022 --> Oct 2021 | Trial primary completion date: Sep 2021 --> Mar 2021
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