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- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab in a very frail population of patients with advanced or metastatic cutaneous squamous cell carcinoma: A monocenter real-life experience from Italy. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_5420;
In our real-life experience cemiplimab showed high antitumor activity with acceptable safety profile similar to those in selected patients of trials . Moreover, its antitumor activity resulted not impaired in very elderly patients or in those with immunocompromized status.
- Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] Network meta-analysis (NMA) of immuno-oncology (IO) monotherapy as first-line (1L) treatments (txs) for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_5298;
Moreover, its antitumor activity resulted not impaired in very elderly patients or in those with immunocompromized status. In advanced NSCLC pts with PD-L1 ≥50%, cemiplimab mono demonstrated significant improvements in PFS and ORR, and comparable OS, safety/tolerability vs pembrolizumab.
- Libtayo (cemiplimab) / Sanofi, Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Budget impact (BI) analysis of cemiplimab-rwlc for advanced basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy in the United States. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4954;
Modest incremental BI is directly attributable to the projected uptake of cemiplimab-rwlc in a market where pts previously received no ST . These analyses provide new insights in the management of advanced BCC noting limited available evidence for post-HHI treatment.
- Libtayo (cemiplimab) / Sanofi, Regeneron, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Budget impact (BI) analysis of cemiplimab for first-line (1L) advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% in the United States. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4941;
Cemiplimab is likely to be associated with a minimal increase in the budget for 1L treatment of advanced NSCLC with PD-L1 ≥50% . With a numerically lower list price relative to pembro and nivo, BI of cemiplimab was driven by the treatment duration for cemiplimab, which was higher than comparator treatments due to increased PFS.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Frequency, characteristics, and subsequent treatment (Tx) of real-world patients (pts) who discontinue hedgehog inhibitors (HHIs) as first-line (1L) systemic Tx for advanced basal cell carcinoma (aBCC). () - Apr 29, 2021 - Abstract #ASCO2021ASCO_4876;
There was no clear standard of care among pts who experienced HHI Tx failure, with only a minority initiating subsequent 2L Tx . Effective Tx strategies for pts who do not respond to or cannot tolerate HHIs are needed.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Deep learning to identify and predict cardiotoxicities of anticancer drugs. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3987;
Our analysis also identified myositis/myocarditis association with newer immune checkpoint inhibitors (e.g., atezolizumab, durvalumab, cemiplimab, avelumab) paralleling earlier signals for pembrolizumab, nivolumab, and ipilimumab . Deep Learning provides a comprehensive insight into emerging cardiotoxicity patterns of approved and investigational drugs, allows detection of ‘rogue’ chemical moieties, and shows promise for novel drug discovery and development.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Association of immune checkpoint inhibitors (ICI) and venous thromboembolism (VTE): A single healthcare system experience. () - Apr 29, 2021 - Abstract #ASCO2021ASCO_3960;
This study is a preliminary analysis and has limitations . At this time, it is unclear if prophylactic anticoagulation can reduce risk of VTE after ICI initiation .
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Review of the Libtayo clinical development program and most recent data leading to new approvals () - Apr 28, 2021 - Abstract #ASCO2021ASCO_3554;
At this time, it is unclear if prophylactic anticoagulation can reduce risk of VTE after ICI initiation . Hosted by Sanofi Genzyme & Regeneron
- Libtayo (cemiplimab) / Sanofi, Regeneron, SAR439459 / Sanofi
[VIRTUAL] Safety, pharmacokinetic and pharmacodynamic results from dose escalation of SAR439459, a TGFβ inhibitor, as monotherapy or in combination with cemiplimab in a phase 1/1b study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2564;
P1
MTD was not reached . Peripheral and tumor target engagement and modulation of key immune cells was observed in treated patients .
- REGN4018 / Regeneron, Libtayo (cemiplimab) / Sanofi, Regeneron, Avastin (bevacizumab) / Roche
[VIRTUAL] A phase I/II, multicenter, open-label study of REGN5668 (mucin [MUC]16 x CD28 bispecific antibody [bsAb]) with cemiplimab (programmed death [PD]-1 Ab) or REGN4018 (MUC16 x CD3 bsAb) in recurrent ovarian cancer (rOVCA). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2216;
P1/2
In expansion, primary endpoint is ORR by RECIST 1.1 for each combination; key secondary endpoints are TEAEs, serious AEs, deaths . Key exploratory endpoints are correlation between clinical efficacy endpoints and baseline protein expression levels of MUC16 and PD-L1.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Winship 4851-19: A pilot study of neoadjuvant and adjuvant cemiplimab for high-risk cutaneous squamous cell carcinoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1898;
P1
We also plan to evaluate the immune profile of fresh tumor and blood to assess the impact of neoadjuvant cemiplimab on the tumor microenvironment and circulating immune responses . To date 5 of 20 patients have been enrolled; this sample size was selected based on feasibility and ability enroll within a timely fashion.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Health-related quality of life (HRQoL) in patients (pts) with locally advanced basal cell carcinoma (laBCC) treated with cemiplimab: Analysis of a phase II, open-label clinical trial. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1871;
P2
To date 5 of 20 patients have been enrolled; this sample size was selected based on feasibility and ability enroll within a timely fashion. In laBCC pts treated with cemiplimab, the majority reported clinically meaningful improvement or stability in GHS/QoL and functional status while maintaining a low symptom burden except for fatigue.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Efficacy of cetuximab after immunotherapy (IO) in advanced cutaneous squamous cell carcinoma (CSCC). () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1867;
If validated in a larger dataset, this should be the preferred therapy for second-line treatment in advanced CSCC . Further exploration into the mechanism of this high efficacy of anti-EGFR therapy post aPD1 therapy is warranted.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Checkpoint inhibition in immunosuppressed or immunocompromised patients with advanced cutaneous squamous cell carcinoma (CSCC): Data from prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1852;
P=N/A
The safety, tolerability, and effectiveness of cemiplimab in this initial cohort of immunosuppressed and/or immunocompromised patients with advanced CSCC appear to be consistent with those observed in clinical trials that excluded these patients . Further follow-up and additional data would add to our general understanding of safety and effectiveness of anti-PD1 therapy in immunocompromised and/or immunosuppressed patient populations overall.
- Libtayo (cemiplimab) / Sanofi, Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
[VIRTUAL] Clinical activity of fianlimab (REGN3767), a human anti-LAG-3 monoclonal antibody, combined with cemiplimab (anti-PD-1) in patients (pts) with advanced melanoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1817;
P1
The safety profile of fianlimab + cemiplimab is similar to that observed with cemiplimab monotherapy and other anti–PD-1s, with the exception of higher rate of adrenal insufficiency . Fianlimab + cemiplimab combination has shown clinical activity for pts with advanced melanoma that is similar to anti–PD-1 + CTLA-4 combination therapy, but with lower demonstrated rates of TEAEs.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab monotherapy as first-line (1L) treatment of patients with brain metastases from advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥ 50%: EMPOWER-Lung 1 subgroup analysis. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1060;
P3
1L cemiplimab monotherapy improved OS, PFS, and ORR vs chemotherapy, in patients with advanced NSCLC with PD-L1 ≥50%, and clinically stable brain metastases at baseline . Cemiplimab monotherapy represents a suitable option for this subgroup of patients.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Patient-reported symptoms, functioning, and quality of life (QoL) in patients treated with cemiplimab monotherapy for first-line treatment of advanced NSCLC with PD-L1 ≥ 50%: Results from EMPOWER-Lung 1 study. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1054;
P3
In pts with advanced NSCLC and PD-L1 expression ≥50%, cemiplimab significantly improved GHS/QoL, functioning, and most symptoms vs chemo . Over 1 year of treatment, cemiplimab delayed worsening of key lung cancer symptoms and functioning.
- Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
[VIRTUAL] PD-(L)1 inhibitors as monotherapy for the first-line treatment of non-small cell lung cancer patients with high PD-L1 expression: A network meta-analysis. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1052;
Current/former smokers ≥65 years, with ECOG PS = 1 and squamous NSCLC benefited most from this therapy . *KEYNOTE-042 was the only study including patients with stage IIIB NSCLC.
- | Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Metastases: Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - Apr 27, 2021
P2, N=33, Not yet recruiting, Sponsor: Marcelo Bonomi
- | Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Tumor mutational burden: NEO-CESQ: Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma (clinicaltrials.gov) - Apr 26, 2021
P2, N=25, Recruiting, Sponsor: Fondazione Melanoma Onlus
*KEYNOTE-042 was the only study including patients with stage IIIB NSCLC. Not yet recruiting --> Recruiting
- ||| BNT111 / BioNTech
Enrollment open: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov) - Apr 25, 2021
P2, N=120, Recruiting, Sponsor: BioNTech SE
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || ISA101 / ISA Pharma
Trial primary completion date: OpcemISA: A Randomized Phase 2 Study of Cemiplimab (clinicaltrials.gov) - Apr 22, 2021
P2, N=194, Recruiting, Sponsor: ISA Pharmaceuticals
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2020 --> Dec 2021
- || ISA101 / ISA Pharma
Trial initiation date, Metastases: ProcemISA: A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC (clinicaltrials.gov) - Apr 22, 2021
P2, N=86, Not yet recruiting, Sponsor: ISA Pharmaceuticals
Trial primary completion date: Nov 2020 --> Dec 2021 Initiation date: Nov 2020 --> May 2021
- || Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=109, Active, not recruiting, Sponsor: Sanofi
Initiation date: Nov 2020 --> May 2021 Trial completion date: Apr 2021 --> Dec 2021 | Trial primary completion date: Apr 2021 --> Dec 2021
- || Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Combination therapy, Monotherapy, PD(L)-1 Biomarker, IO biomarker: PD-1/PD-L1 inhibitor monotherapy or in combination with chemotherapy as upfront treatment for advanced NSCLC with PD-L1 expression ≥ 50%: selecting the best strategy. (Pubmed Central) - Apr 21, 2021
Nevertheless, a significant difference in terms of early progression-free survival rate emerges by analyzing and comparing the survival curves of the two strategies, reflecting a non-negligible loss of patients due to early disease progression at 3 and 6 months from treatment initiation with immunotherapy alone as compared to its association with chemotherapy. We deeply analyzed efficacy similarities and differences of the two approaches in advanced NSCLC with PD-L1 expression ≥50%, trying to suggest clinical and biologic aspects to be considered when facing the treatment choice.
- ||| Sarclisa (isatuximab-irfc) / Sanofi
Trial completion, Combination therapy, Metastases: Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies (clinicaltrials.gov) - Apr 21, 2021
P1/2, N=134, Completed, Sponsor: Sanofi
We deeply analyzed efficacy similarities and differences of the two approaches in advanced NSCLC with PD-L1 expression ≥50%, trying to suggest clinical and biologic aspects to be considered when facing the treatment choice. Active, not recruiting --> Completed
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Enrollment change, Surgery: C-POST: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - Apr 20, 2021
P3, N=412, Recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed Active, not recruiting --> Recruiting | N=75 --> 412
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Checkpoint inhibition: #Cemiplimab is now the 3rd checkpoint blockade therapy for #NSCLC, but redundant therapy brings up ethical concerns when physicians prescribe obsolete standards of care, finds new study. https://t.co/IRgjpRDr35 via @JackWestMD (Twitter) - Apr 20, 2021
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Checkpoint inhibition: Cemiplimab is now the 3rd checkpoint blockade therapy for #NSCLC, but redundant therapy brings up ethical concerns when physicians prescribe obsolete standards of care, finds new study. https://t.co/9bULZfl2R1 via @JackWestMD (Twitter) - Apr 20, 2021
- |||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: NEW Perspective from Ghassan K. Abou-Alfa, MD, MBA @sloan_kettering analyzes recent study results from #AACR21 showing neoadjuvant cemiplimab leads to tumor necrosis in early-stage hepatocellular carcinoma @GABOUALFA https://t.co/GDt4dCPuwB (Twitter) - Apr 20, 2021
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Checkpoint inhibition: Medscape: Cemiplimab is now the 3rd checkpoint blockade therapy for #NSCLC, but redundant therapy brings up ethical concerns when physicians prescribe obsolete standards of care, finds new study. https://t.co/18xjjPtk91 via @JackWestMD #lcsm … https://t.co/JFzr3BZsvF (Twitter) - Apr 19, 2021
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Checkpoint inhibition: Cemiplimab is now the 3rd checkpoint blockade therapy for #NSCLC, but redundant therapy brings up ethical concerns when physicians prescribe obsolete standards of care, finds new study. https://t.co/ntXg0fPua5 via @JackWestMD #lcsm (Twitter) - Apr 18, 2021
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab in advanced cutaneous squamous cell carcinoma: UK experience from the Named Patient Scheme () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_772;
The rapid progression of the 9 patients whilst waiting to start Cemiplimab, suggests that time is of essence to initiate Cemiplimab therapy to enable patients to have a chance to respond. Further follow up is needed to assess durability of Responses.
- Libtayo (cemiplimab) / Sanofi, Regeneron, Yervoy (ipilimumab) / Ono Pharma, BMS
[VIRTUAL] Pseudoprogression in ACSCC tumors () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_771;
In this type of tumors, physical examination with respect to CT scan allows physicians to evaluate lesions evolution more frequently. Without rapid clinical deterioration, we recommend administrated Cemiplimab despite of early cutaneous changes.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Deceleration in the rate of keratinocyte cancers and pre-cancerous lesions during PD-1 inhibition for advanced melanoma, with recrudescence on discontinuation () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_764;
In Europe, approval only exists for cemiplimab3,4. Deinlein et al5 report 12 case reports outlining the response of cutaneous SCC with locally advanced disease to pembrolizumab up to 2017; more cases are reported since1,2,6,7,8,9,10.
- Keytruda (pembrolizumab) / Merck (MSD)
[VIRTUAL] KEYNOTE 629: Phase 2 study of pembrolizumab monotherapy for locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_758;
P2
Safety was manageable and consistent with the previously reported safety profile for pembrolizumab. These results support the use of pembrolizumab for the treatment of LA and R/M cSCC
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC): follow-up at 43 months () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_757;
The 43-month follow-up from this study shows incremental improvements in DOR with cemiplimab treatment across all advanced CSCC study groups, as well as improvements in ORR and complete response rate on the cemiplimab 350 mg Q3W regimen. There were no new safety signals.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Pilonidal sinus squamous cell carcinoma: a rare complication of a cronic infection: a single center retrospective study and literature review () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_747;
CSCC of pilonidal sinus is an extremely rare complication of a cronic infection of pilonidal sinus. This tumour has poor prognosis due to infections of local relapses, despite surgical management, with an overall survival less than one year.
- [VIRTUAL] Two patients treated with Hedgehog inhibitor (HHI) and anti-PD-1 antibody for concomitant diagnosis of advanced Basal Cell Carcinoma (aBCC) and cutaneous Squamous Cell Carcinoma (cSCC) () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_535;
P1, P2
In our small experience, this combination did not show new or intolerable adverse events. Ongoing trials are evaluating the combination of HHI and anti-PD-1 drugs in aBCC (NCT04679480) and in other malignancies (NCT04007744).
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] PD-1 inhibitors for advanced basal cell carcinoma: where do we stand? () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_533;
In contrast, multiple phase I and phase II trials have been completed for the treatment of cutaneous squamous cell carcinoma. The lack of completed studies may be due to the challenges of recruiting patients with a much rarer disease entity: aBCC.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Primary analysis of Phase 2 results for cemiplimab in patients with locally advanced basal cell carcinoma who progress on or are intolerant to hedgehog inhibitors () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_531;
Previously presented at ESMO 2020, FPN LBA47, Stratigos et al. Reused with permission.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Interim analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma who progressed on or are intolerant to hedgehog inhibitors () - Apr 18, 2021 - Abstract #EADOWCM2021EADO-WCM_530;
P2
This abstract was accepted and previously presented at the 2020 SITC Annual Meeting. Reused with permission.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cost-effectiveness of cemiplimab in the US for the first-line treatment of patients with advanced nonsmall cell lung cancer (ANSCLC) and programmed death-ligand 1 (PD-L1) expression ≥50% () - Apr 17, 2021 - Abstract #AMCP2021AMCP_331;
P3
Reused with permission. Cemiplimab compared with pembrolizumab is a cost-effective first-line treatment option for patients with aNSCLC and PD-L1 expression ≥50%.
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Can we use IO alone? Sure. There are now 3 (!!!) approved agents - pembrolizumab, atezolizumab and cemiplimab. Or should we use chemoIO? We have plenty of those too (see above). How might KRAS MT status help us decide? #LCSM #Immunotherapy @kRasKickers (Twitter) - Apr 15, 2021
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Variability in the Dosing of PD1 Inhibitors Used for Treatment of Non-melanoma Skin Cancers () - Apr 10, 2021 - Abstract #AADVMX2021AAD_VMX_428;
However, the literature shows a wide range of dosing regimens for these therapies. Further studies are needed to guide clinicians towards the optimal dosage and the ideal anti-PD1 agent for their patients.
- || Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: CME Part I: Immune checkpoint inhibitors to treat cutaneous malignancies. (Pubmed Central) - Apr 10, 2021
This article reviews the indications, efficacy, safety profile and evidence supporting checkpoint inhibition as therapeutics for metastatic melanoma, cutaneous squamous cell carcinoma, and Merkel cell carcinoma. Pivotal studies resulting in the approval of ipilimumab, pembrolizumab, nivolumab, cemiplimab and avelumab by regulatory agencies for various cutaneous malignancies, as well as ongoing clinical research trials, are discussed.
- || Libtayo (cemiplimab) / Sanofi, Regeneron
P1 data, Journal, PD(L)-1 Biomarker, IO biomarker: PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. (Pubmed Central) - Apr 10, 2021
Cemiplimab has activity in cervical squamous cell carcinoma. The phase I results, combined with results from other anti-PD-1 trials in cervical cancer and our biomarker analyses have informed the design of the ongoing phase III trial, with the primary overall survival hierarchical analyses being done first in patients with squamous histology.
- | Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: Immuno oncology treatment in head and neck cancer (Pubmed Central) - Apr 10, 2021
Nivolumab and Pembrolizumab are currently approved in Germany for the first and second line therapy of relapsed/metastatic squamous cell carcinoma of the head and neck region (HNSCC), Cemiplimab for recurrent/metastatic cutaneous squamous cell carcinoma and Avelumab for metastatic recurrent Merkel-cell carcinoma. The synopsis article about immune checkpoint inhibitors is intended to convey the basic understanding of the principle of action, the indication, toxicity management and the further development within trials in head and neck oncology.
- | sirolimus / Generic mfg.
Journal: Update of the Management of Cutaneous Squamous-cell Carcinoma. (Pubmed Central) - Apr 7, 2021
Platin-based chemo or anti-EGFR therapies are possible second-line treatments. For transplant patients, minimizing immunosuppression and switching to sirolimus must be considered at first appearance of cSCC.
- | sirolimus / Generic mfg.
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: Biomarkers Predicting for Response and Relapse with Melanoma Systemic Therapy. (Pubmed Central) - Apr 7, 2021
To date, the only validated biomarker applied to selecting melanoma systemic therapy is the BRAF gene. However, modern technologies are now opening up a wide range of candidate genes, polypeptides and proteins which are being evaluated for their potential clinical application as predictive biomarkers of the future.