Semdexa (dexamethasone) / Sorrento - LARVOL DELTA

Analyzing neuropathic pain subjects in acute low back pain using an NPSI-based stratification algorithm and PainDETECT measurement (NeuPSIG 2025) - "study, an RCT on SP-102 transforaminal injections for lumbosacral radicular pain... Our findings support the feasibility of using a pre-defined NPSI-based clustering algorithm to stratify neuropathic phenotypes using the PainDETECT in patients with acute low back pain and radiculopathy. However, the inherent difference of PainDETECT - not assessing pressing pain - limits its ability to fully replicate the three-cluster model of the NPSI. Consequently, for characterization neuropathic pain subtypes, PainDETECT is most appropriately applied in a two-cluster model (Pinpointed Pain and Evoked Pain), while the NPSI remains the more comprehensive tool for phenotyping."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Pain

Scilex Holding Company Announces Positive Type C Meeting with the FDA and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXA) in Lumbosacral Radicular Pain (Sciatica) (GlobeNewswire) - "Scilex Holding Company...today announced a positive Type C meeting with the U.S. Food and Drug Administration ('FDA'). The Company has reached agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application ('NDA')...Recently, during the Type C meeting with the FDA, the Company received an advisement on expectations and requirements to file the NDA, including clinical and preclinical data...Based on the advisement received, Scilex is planning to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it will seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an epidural steroid injection. SP-102 (SEMDEXA^TM) is expected to be administered in up to 3 injections during a 6-month observation period. Completion of enrollment in the trial is projected to occur in 2025."

FDA event • New trial • CNS Disorders • Pain

Carfilzomib-Lenalidomide-Dexametasone (Krd) Vs. Lenalidomidedexametasone (Rd) In Newly Diagnosed Fit Or Intermediate Patients Fit With Multiple Myeloma Not Suitable For Autologous Transplant: Emn20 Phase III Randomized Trial (SIE 2023) - P3 | N=101 | EMN20 (NCT04096066) | "The analysis of the primary MRD endpoint is planned when all pts have received treatment for 2 y (Q4 of 2023): results will be presented at the meeting."

P3 data

Larson Reviews Combination Therapy Plus Transplant in Newly Diagnosed Multiple Myeloma (Targeted Oncology) - "LARSON: The NCCN [National Comprehensive Cancer Network] guidelines, which are always in the process of revision because of all the new data that are always coming out, list the preferred regimens...Another recommended regimen is daratumumab [Darzalex], lenalidomide, bortezomib, and dexamethasone [D-VRd]."

Media quote

Multiple Myeloma Face-off: Ravi Vij, MD, MBA and Luciano J. Costa, MD, PhD, Discusses Readout of ASH 2022 Data : Episode 6: Ongoing Trials Aim to Determine Best Regimen for Transplant-Ineligible Patients With Myeloma (Cancer Network) - "Luciano J. Costa, MD, PhD, discussed additional studies evaluating various treatment regimens for transplant-ineligible patients with newly diagnosed multiple myeloma, aiming to determine the best standard in this population."

Video

Deep & Durable Responses for Quadruple Therapy in Smouldering MM (Physician’s Weekly) - '"Smoldering MM is a so-called precursor condition, and patients with this condition have a high risk to progress to active MM,' explained Dr. Shaji Kumar....'After 2 years, many patients that were included in this study are still in deep response,' said Dr. Kumar. 'Are we able to actually cure some of these patients? The answer to that question has to come from long-term follow-up."

Media quote

Daratumumab + lenalidomide/dexamethasone in transplant-ineligible NDMM: MAIA age subgroup analysis (JSH 2022) - No abstract available.

Advances in Multiple Myeloma: Insights from Experts at Emory University on Translating Evidence to Clinical Practice - Episode 8: Transplant-Ineligible Multiple Myeloma: The SWOG0777 Study (Cancer Network) - "Sagar Lonial, MD: It brings up the idea and concepts around PFS [progression-free survival] benefit and potentially overall survival benefit of the different regimens we have. When we think about RVd as a backbone, the 2 trials that looked at this without a transplant are the SWOG S0777 trial, where the median PFS was around 2½ to 3 years, somewhere in that ballpark, and the ENDURANCE [NCT01863550] trial that you mentioned, which also looked at nontransplant RVd vs KRd [carfilzomib, lenalidomide, dexamethasone]. The median PFS is somewhere around 36 months in that one as well, with the hypothesis that K [carfilzomib] was going to be significantly better in a standard-risk patient population."

Video

Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., to Present SP-102 (SEMDEXA) Efficacy and Safety Data from its Pivotal Phase 3 Clinical Trial Program for Sciatica Pain Management at the 24th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP) in Las Vegas, NV. (GlobeNewswire) - "Scilex Holding Company...announced that it will be presenting SP-102 (SEMDEXA™) efficacy and safety data from its Pivotal Phase 3 clinical C.L.E.A.R trial program (Corticosteroid Lumbosacral Epidural Analgesia for Radiculopathy) for sciatica pain management at the 24th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP) on May 5, 2022 in Las Vegas, NV."

P3 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Scilex Holding Company, a majority-owned subsidiary of Sorrento Therapeutics, Inc., enters into a Non-Binding Term Sheet for a $5 Billion Committed Equity Financing Facility to be Effective in Connection with the Closing of the Merger with Vickers Vantage Corp I (GlobeNewswire) - "Scilex Holding Company...announced that it has entered into a non-binding term sheet with B. Riley Principal Capital, LLC...for a committed equity financing facility (the 'Facility') under which it would be able to sell up to $5 billion of its registered common stock over a five-year period. The Facility would become effective in connection with the closing of the previously announced pending merger with Vickers Vantage Corp I ('Vickers'). Scilex would not be obligated to utilize any of the $5 billion facility and would be able to enter other financing transactions. No warrants will be issued in connection with the Facility....'As we prepare to begin our registration and pre-commercialization plans of our recently successfully completed SP-102 (SEMDEXATM) Phase 3 clinical trial program, this Facility is an important addition to our menu of financing options...'"

Financing • Central Neuropathic Pain • CNS Disorders • Pain

ASH 2021: The Role of Antibody Platforms in Newly Diagnosed Multiple Myeloma: Frontline Use of Daratumumab (Myeloma Crowd) - "Dr. Suzanne Lentzsch...started the session by discussing how antibodies are changing the care of both transplant-eligible and transplant-ineligible patients with newly diagnosed multiple myeloma. Three drug regimens, an immunomodulating agent (Revlimid), a proteasome inhibitor (Velcade), in combination with a steroid (dexamethasone) is standard induction therapy for most patients with newly diagnosed multiple myeloma. Adding daratumumab, a CD38 monoclonal antibody to RVd therapy shows encouraging results. An update on the GRIFFIN study which studied use of Dara+RVd with individuals newly diagnosed with myeloma will be provided at ASH- stay tuned for more details on the progress of that study."

Media quote

Dr. Manasanch on Key Takeaways From CASSIOPEIA in Multiple Myeloma (OncLive) - P3, N=NA; CASSIOPEIA (NCT02541383); "Elisabet E. Manasanch, MD...discusses key lessons learned from the phase 3 CASSIOPEIA trial (NCT02541383) in patients with newly diagnosed multiple myeloma. CASSIOPEIA enrolled patients who were eligible for high-dose chemotherapy and autologous stem cell transplant. The trial examined the administration of daratumumab plus bortezomib (Velcade), thalidomide, and dexamethasone (VTd) vs VTd only. Results showed that patients who received daratumumab up front had a longer progression-free survival (PFS) and overall survival (OS) than those who did not, according to Manasanch."

P3 data • Video

Updates in Newly Diagnosed and Relapsed/Refractory Multiple Myeloma from ASH 2021 - Episode 9: Relapsed/Refractory MM: Results From the BELLINI Study (OncLive) - "Saad Z. Usmani, MD: Venetoclax is a highly selective potent oral BCL2 inhibitor. We know that myeloma is a cancer that has terminally differentiated plasma cells that do typically express elevated levels of anti-apoptotic proteins, including BCL2....I hope that we are able to continue to develop venetoclax for these patients, either with proteasome inhibitors or with other drug classes, but develop this as a biomarker-driven therapy just for that subgroup of patients who benefited."

Video

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (clinicaltrials.gov) - P3 | N=401 | Completed | Sponsor: Scilex Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Pain

A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 (clinicaltrials.gov) - P2; N=19; Completed; Sponsor: Semnur Pharmaceuticals, Inc.; Phase classification: P1 ➔ P2

Clinical • Phase classification • Pain

Scilex Holding Company, a Sorrento Therapeutics, Inc. Subsidiary, Announces Highly Significant Positive Top-Line Results from its Phase 3 Non-Opioid Injectable SP-102 (SEMDEXA) Pivotal Trial C.L.E.A.R. Program for Sciatica Pain Management Supporting the Potential Use of SP-102 as a Best-in-Class Therapy (GlobeNewswire) - "Scilex Holding Company a subsidiary of Sorrento Therapeutics, Inc...today announced highly significant positive top-line results from its SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program, a corticosteroid injectable dexamethasone sodium phosphate viscous gel for the treatment of lumbosacral radicular pain, or sciatica....The primary endpoint of change in average daily pain in the affected leg over 4 weeks following the initial injection had demonstrated LS Mean (SE) group difference of -1.08 (0.17) compared to placebo with a p-value <0.001. The two key secondary endpoints assessing Oswestry Disability Index (ODI) and Time to open-label repeat injection had also demonstrated highly statistically significant results."

P3 data: top line • CNS Disorders • Pain

The Impact of Evolving Treatment Options in Multiple Myeloma, Part 5 (AJMC) - "Joseph Mikhael, MD: The GRIFFIN trial is sentinel in our next phase of approaching frontline therapy for myeloma, in particular, for those who are going to transplant, but ultimately over time, even those patients who are not going to transplant....We are definitely seeing MRD rates that historically were unheard of in myeloma, let alone complete remission [CR] rates, too. In the past, we'd be happy to get a small fraction of our patients into true CR, and now we're seeing two-thirds, three-quarters, over 80% of them achieving them with these quadruplets."

Video

[VIRTUAL] SP102. Breast (ACS-CLINCON 2021) - No abstract available

Shaji Kumar, ASCO 2021: The EQUATE Trial, a Quadruplet Regimen for Multiple Myeloma (Touch Oncology) - "We were delighted to talk with Dr Shaji Kumar...about the EQUATE trial, developing a quadruplet regimen for newly-diagnosed multiple myeloma, including bortezomib, lenalidomide, dexamethasone and daratumumab."

Video

Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (clinicaltrials.gov) - P3; N=400; Active, not recruiting; Sponsor: Scilex Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Pain

Scilex Holding Company, a Sorrento Company, Announces Complete Enrollment on Non-Opioid Injectable SP-102 (SEMDEXA) Phase 3 Pivotal Trial C.L.E.A.R. Program For Sciatica Pain Management (GlobeNewswire) - "Scilex Holding Company...announced complete enrollment of its SP-102 (SEMDEXA™) Phase 3 Pivotal Trial C.L.E.A.R. Program for its novel, non-opioid, corticosteroid formulation, injectable dexamethasone sodium phosphate viscous gel product for the treatment of lumbosacral radicular pain (sciatica)....Top-line data from the study is expected in Q4 2021...'we plan to request a meeting with the US Food and Drug Administration (FDA) by the first half of 2022 to negotiate NDA filing,'...By 2022, the overall estimated number of epidural steroid injection (ESI) procedures in the U.S. is expected to be 12.1 million across all Medicare and private coverage patients, with lumbar radiculopathy/sciatica procedures comprising approximately 88% of all ESIs administered, according to a proprietary study by Syneos Health."

Enrollment closed • FDA event • P3 data: top line • Reimbursement • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. (PubMed, J Pain Res) - P1 | "A phase III trial is ongoing. ClinicalTrials.gov: NCT03613662."

Clinical • Journal • Back Pain • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

D-Pd Improves PFS vs Pd Alone in Relapsed/Refractory Multiple Myeloma (Cancer Therapy Advisor) - '"In the first phase 3 study of subcutaneous daratumumab given in combination [with] Pd significantly reduced the risk of progression or death by 37% vs Pd in patients with RRMM who had received at least 1 line of prior therapy,' Meletios A. Dimopoulos, MD...said....Dr Dimopoulos concluded by stating these data show that D-Pd 'is an effective and convenient treatment for patients with RRMM who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor.'"

Media quote

ASH 2020 | Iberdomide-based regimens in R/R multiple myeloma (VJHemOnc) - "P=1/2, N=NA; Niels van de Donk, MD, PhD...discusses the results of a Phase I/II CC-220-MM-001study (NCT02773030) of iberdomide (IBER) with different treatment combinations in relapsed/refractory (R/R) multiple myeloma patients. Patients were divided into separate cohorts receiving IBER plus daratumumab plus dexamethasone (IberDd), or IBER plus bortezomib plus dexamethasone (IberVd). The maximum tolerable dose was not reached and the general safety profile of both treatments was found acceptable, with few serious adverse events being reported. In the IberDd arm, the overall response rate was 42%, compared to 60% in the IberVd cohort. Both triplets were generally tolerable and had promising clinical benefit in R/R multiple myeloma, supporting the continued investigation of IBER-based treatment regimens. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020."

Clinical data • Video

Oncopeptides Announces National Comprehensive Cancer Network Adds PEPAXTO (melphalan flufenamide) to Its Multiple Myeloma Clinical Practice Guidelines (PRNewswire) - “Oncopeptides…announced that PEPAXTO® (melphalan flufenamide) has been added to the Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) in Oncology. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.”

NCCN guideline • Hematological Malignancies • Multiple Myeloma • Oncology