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Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity, in combination with lazertinib is being evaluated for the first-line treatment of patients with EGFR-mutated non-small cell lung cancer.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2024
Details:
JNJ-73841937 (lazertinib) is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation. It is under phase 3 clinical development in combination with Rybrevant (amivantamab) for the treatment of EGFR-mutated non-small cell lung cancer.
Lead Product(s): Lazertinib,Amivantamab-vmjw
Therapeutic Area: Oncology Product Name: JNJ-73841937
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Details:
Rybrevant (amivantamab) is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directing activity. It is being evaluated in combination with lazertinib for the treatment of patients with EGFR-mutated non-small cell lung cancer.
Lead Product(s): Amivantamab,Lazertinib,Carboplatin
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Details:
Rybrevant (amivantamab) is a fully-human EGFR-MET bispecific antibody. It is being evaluated in combination with Lazertinib & chemotherapy for the treatment of adult patients with advanced egfr-mutated non-small cell lung cancer after failure of prior therapy.
Lead Product(s): Amivantamab,Lazertinib,Pemetrexed
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2023
Details:
Rybrevant (amivantamab-vmjw), a fully-human bispecific antibody targeting EGFR and MET, which is investigated in combination with lazertinib for the treatment in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
Lead Product(s): Amivantamab-vmjw,Lazertinib,Pemetrexed
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2023
Details:
Rybrevant® (amivantamab-vmjw) extracellular domains of EGFR and MET which disrupts EGFR and MET signaling functions through blocking ligand binding and, in exon 20 insertion mutation models, degradation of EGFR and MET.
Lead Product(s): Amivantamab-vmjw,Lazertinib,Carboplatin
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2023
Details:
After median follow-up of 7.1 months, combination of RYBREVANT (amivantamab-vmjw)and lazertinib with carboplatin and pemetrexed yielded an overall response rate (ORR) of 50 percent (95 percent confidence interval [CI];27-73), with 15 out of 20 patients remaining on treatment.
Lead Product(s): Amivantamab-vmjw,Lazertinib,Carboplatin
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2022
Details:
Conditional Marketing Authorisation of RYBREVANT® (amivantamab) is based on results from the Phase 1 CHRYSALIS study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy.
Lead Product(s): Amivantamab-vmjw,Lazertinib
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
CHRYSALIS-2 findings suggest that RYBREVANT® and lazertinib combination has encouraging anti-tumor activity, particularly NSCLC with EGFR exon 20 insertion mutation in this population that has exhausted standard-of-care treatments.
Lead Product(s): Amivantamab-vmjw,Lazertinib
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2021
Details:
ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer and for the treatment of patients with metastatic castration-sensitive prostate cancer.
Lead Product(s): Amivantamab-vmjw,Lazertinib
Therapeutic Area: Oncology Product Name: Rybrevant
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
The Phase 3 MARIPOSA study will assess the amivantamab and lazertinib combination against osimertinib in untreated EGFR-mutated NSCLC and CHRYSALIS-2 has been initiated to examine the combination in patients who have progressed after treatment with osimertinib & chemotherapy.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: JNJ-61186372
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2021
Details:
The key findings showed robust activity and durable responses with a tolerable and manageable safety profile of Amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations, a mutation for which no targeted therapies are currently approved.
Lead Product(s): Amivantamab,Lazertinib,Carboplatin
Therapeutic Area: Oncology Product Name: JNJ-61186372
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2021
Details:
The Ministry of Food and Drug Safety announced its approval for the third-generation non-small cell lung cancer treatment, Leclaza. Leclaza is a swallowable tablet that can be taken at a fixed time every day, regardless of meals.
Lead Product(s): Lazertinib
Therapeutic Area: Oncology Product Name: Leclaza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2021
Details:
Updated amivantamab data from the Phase 1 CHRYSALIS study and new data characterizing the high unmet need among patients with non-small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations to be presented.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: JNJ-61186372
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2021
Details:
The BLA submission is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib*, in adult patients with advanced NSCLC.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: JNJ-61186372
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
Phase 1b study shows bispecific antibody amivantamab and third-generation tyrosine-kinase inhibitor (TKI) lazertinib achieved a 100 percent overall response rate (ORR) in treatment-naïve EGFR-mutated NSCLC patient cohort.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: JNJ-61186372
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2020
Details:
Amivantamab-treated patients achieved durable remissions in CHRYSALIS study; data will be presented during ASCO Virtual Scientific Program.
Lead Product(s): Amivantamab,Lazertinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020