Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots:

  • The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant)
  • Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as reported at ESMO 2020
  • Libtayo is a mAb targeting PD-1 on T-cells, currently under the US FDA’s PR for advanced NSCLC with an expected PDUFA date as Feb 28, 2021. EMA is assessing Libtayo in advanced NSCLC with ≥50% PD-L1 expression & LA BCC following treatment with HHI with anticipated EC’s decision in mid 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Print

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Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Shots:

  • The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium
  • The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen has several P-Ib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrolment
  • Sotorasib is being studied in the a clinical program exploring 10 combinations with global sites across the four continents

Click here ­to­ read full press release/ article | Ref: Amgen | Image: BioSpace

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Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots:

  • The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC
  • Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage among all responders was 60% and complete responses observed
  • Sotorasib is 1st KRAS G12C Inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Fierce Pharma

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BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Shots:

  • The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC
  • The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified
  • Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The approval marks the third approval for tislelizumab in China and its first in a lung cancer indication

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Memorial Sloan Kettering Cancer Center

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Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Shots:

  • Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21
  • The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic NET & pancreatic NET patients with an acceptable risk/benefit ratio
  • Surufatinib is an oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR. The US FDA has granted FTD to surufatinib for pancreatic and non-pancreatic NET in Apr’2020 and ODD for pancreatic NET in Nov’2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PMLive

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Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots:

  • The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
  • The study provided durable anticancer activity with a positive benefit-risk profile
  • The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Axios

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Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Shots:

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Handelsblatt

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Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Shots:

  • Zymeworks will conduct a P-Ib study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in a two-part study
  • The 1st part will evaluate the safety of the combination regimen while the 2nd part will assess the safety, tolerability, and anti-tumor activity in separate cohorts of subjects with HER2+ BC, HER2-low BC, and non-breast HER2-expressing solid tumors
  • Zanidatamab is in the advanced clinical stage, actively enrolling a study in patients with prior treated HER2 gene-amplified BTC while five active P-II programs are underway. ALX148 is a next-generation CD47 blocker and has the potential to expand the chance for zanidatamab to benefits patients with HER2‑expressing BC

Click here ­to­ read full press release/ article | Ref: Zymeworks | Image: Medium

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AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Shots:

  • The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab
  • Results: reduction in risk of disease progression or death by 67%, PFS (37.2mos. vs 17.7mos.); PFS2 (50.3mos. vs 35.3mos.)
  • Following the approval, AZ will receive $25M as a regulatory milestone from MSD. The approval follows the CHMP’s positive opinion granted in Sept’2020

Click here to­ read the full press release/ article | Ref: AstraZeneca | Image: Pharmaceutical Technology

The post AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer first appeared on PharmaShots.

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots:

  • The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC
  • The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while the median duration of follow-up was 34.6 mos.
  • Kisqali is a selective cyclin-dependent kinase inhibitor, acts by inhibiting two proteins called CDK4/6

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Law

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GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

Shots:

  • The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count
  • Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula reduced the risk of disease progression or death vs. pbo by 57% and the risk of disease progression or death vs. pbo by 38% in the overall population. Additionally, risk of progression in those with BRCA mutation tumours showed 60% reduction
  • Zejula is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. It is the first PARP inhibitor approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer

Click here to­ read the full press release/ article | Ref: Abbvie | Image: Spiegel

The post GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer first appeared on PharmaShots.

STADA Expands its Specialty Footprint with the Acquisition of Lobsor Pharmaceuticals

Shots:  

  • STADA acquires Lobsar and its innovative therapy to foster its footprints in specialty pharmaceuticals. The acquisition complements STADA’s portfolio and expertise in the treatment of late-stage Parkinson’s disease
  • With the acquisition, STADA gain rights to a triple fixed combination (levodopa/carbidopa/ entacapone) delivered via modern pump technology, already launched in Nordic countries
  • Levodopa, carbidopa and entacapone infusion therapy is inserted in the small intestine through a discreet, wearable pump. The infusion is approved in Sweden, Denmark, Norway, and Finland, while STADA is currently submitting approval applications to launch the therapy in multiple EU markets

Click here ­to­ read full press release/ article | Ref: STADA | Image: S

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Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots:

  • The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients
  • Result: in NTRK fusion+ solid tumors, ORR (63.5%); mDoR (12.9mos.); In ROS1+ advanced NSCLC, shrank tumors in 73.4% of patients; DoR of 16.5mos. (14.6-28.6mos.); ORR (67.1%); in patients with CNS metastases with an intracranial ORR (62.5% & 77.8%); In pediatric patients, Rozlytrek shrank tumors in all children and adolescents who had NTRK gene fusions with two achieving a CR
  • Rozlytrek (entrectinib, qd) is a tumor-agnostic treatment for LA/m-solid tumors harboring NTRK1/2/3 or ROS1 gene fusions and has received EMA’s PRIME designation to treat NTRK fusion-positive, LA/m- solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots:

  • The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma
  • Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. The review was conducted under Project Orbis
  • Tecentriq is a mAb targeting PD-L1, acts by blocking is its interactions with both PD-1 and B7.1 receptor. Cotellic is a MEK1/2 inhibitor in a cell signaling pathway that helps control cell growth and survival while Zelboraf is a prescription medicine for melanoma that has spread to other parts of the body or cannot be removed by surgery and has a BRAF V600 mutation

Click here ­to­ read full press release/ article | Ref: Roche | Image: StraitTimes




Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Shots:

  • Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
  • The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and tolerability and determine the recommended P-II dose and as preliminary anti-tumor activity of ONCR-177 as monothx. & combination therapy
  • The planned expansion cohorts will include patients with BC, SCCHN, and melanoma. ONCR-177 is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy and is armed with oHSV, IL-12, CCL4, FLT3LG, anti-PD-1 and anti-CTLA-4 designed to stimulate multiple arms of the immune system

Click here to read full press release/ article | Ref: Oncorus | Image: Pitt Innovation System