Update for May 25, 2021

Regulatory Update
 
The FDA approved amivantamab (Rybrevant, Johnson & Johnson), on 5/21/2021, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
 
The EMA’s CHMP recommended approval of elivaldogene autotemcel for the treatment of Cerebral Adrenoleukodystrophy and odevixibat for the treatment of Progressive Familial Intrahepatic Cholestasis.
 
The FDA accepted the NDA for maribavir for the treatment of resistance or refractory cytomegalovirus infection in transplant recipients and set a PDUFA date for 10/26/2021.
 
Announced Research Updates
 
ImmunoGen announced that in a 60 patient cohort enrolled in the Phase Ib FORWARD II trial, treatment with the combination of mirvetuximab and bevacizumab resulted in an ORR of 50% overall and 64% in patients with high FR-Alpha expression in patients with FR-alpha, platinum-resistant ovarian cancer.
 
Lilly announced that in the 52-week, 2,002 patient, Phase III, SURPASS-4 trial, treatment with tirzepatide reduced HbA1c by 2.24% to 2.58% and body weight by 7.1 Kg to 11.7 kg compared to an HbA1c decrease of 1.44% and 1.9 Kg gain with insulin glargine in inadequately controlled type 2 diabetics with increased cardiovascular risk.
 
BeiGene announced that an interim analysis of the 263 patient, Chinese Phase III, RATIONALE 309 trial, suggested that treatment with tislelizumab plus gemcitabine and cisplatin improved progression free survival compared to gemcitabine and cisplatin alone in patients with recurrent or metastatic nasopharyngeal cancer. 
 
Ferring announced that in the 8-week, 267 patient, Phase III, PUNCH CD3 trial, 69.6% of patients treated with a single dose of RBX2660 developed C. difficile diarrhea compared to 41.9% who received placebo in adults who had at least one recurrence after a primary episode of C. difficile infection. 
 
Aveo announced that in a 60 patient, Phase II trial, treatment with ficlatuzumab plus cetuximab resulted in progression free survival of 3.6 months compared to 1.8 months with ficlatuzumab in patients with metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab.
 
Seres announced that in 24-week, 182 Phase III, ECOSPOR III trial, 21.3% of patients treated with SER-109 developed a C. difficile infection compared to 47.3% with placebo in patients with recurrent C. difficile infection.
 
NGM announced that in the 24-week, 171 patient, Phase IIb, ALPINE 2/3 trial, patients treated with aldafermin did not demonstrate an improvement in fibrosis by at least one stage with no worsening of steatohepatitis compared to placebo in patients with biopsy-confirmed NASH with F2-F3 liver fibrosis.
 
Takeda announced that in a follow-up of the TIDES trial, the effectiveness of the TAK-003 Dengue vaccine was found to be 62% and hospitalizations were avoided in 83.6% of patients three years after the second vaccination.
 
Published Research Updates
 
In a 125 patient, Phase II trial, 46% of patients treated with veliparib plus radiotherapy, followed by adjuvant veliparib and temozolomide achieved progression-free survival at 6 months compared to 31% treated with temozolomide and radiotherapy, followed by adjuvant temozolomide in patients with glioblastoma with unmethylated O 6-methylguanine-DNA methyltransferase (MGMT) promoter status. There was no difference in overall survival (12.7 vs 12.8 months).
 
In a 48-week, 259 patient, Phase II trial, 32% to 42% of patients treated with oteseconazole achieved clinical and mycological cure compared to none with placebo in patients with moderate-to-severe distal and lateral subungual onychomycosis of the toenail.
 
In a 24-week, 264 patient, Phase II trial, CRP was lowered more that placebo by 66.2% with ziltivekimab 7.5 mg, 77.7% with 15 mg and 87.8% with 30 mg at 12-weeks, with the results remaining stable to 24-weeks, in patients with moderate to severe chronic kidney disease, and CRP of at least 2 mg/L.
 
In the U.S./Canadian cohort of the 12-month, 1,864 patient, Phase III, open label, E4 Freedom trial, treatment with estetrol 15 mg in combination with drospirenone 3 mg result in a Pearl Index (PI) of 2.65, method failure PI of 1.43 and 13-cycle life-table pregnancy rate of 2.1% among 1,674 women 16-35. Efficacy data was not reported in the 190 women who were 36 to 50.
 
In an 8-week, 162 patient, Phase IIa trial, cannabidivarin was no different from placebo in decreasing the frequency of focal seizures (40.5% reduction vs 37.7% reduction) in patients with inadequately controlled focal seizures.
 
In the 12-week, 662 patient Phase III, ZEAL 1 trial, treatment with fevipiprant did not result in a significant improvement in FEV1 compared to placebo (112 ml vs 71 ml) in patients with uncontrolled asthma. In the 12-week, 685 patient Phase III, ZEAL 2 trial, treatment with fevipiprant did not result in a significant improvement in FEV1 compared to placebo (126 ml vs 157 ml) in patients with uncontrolled asthma.
 
In a 120 patient, Chinese, Phase II study treatment with anlotinib resulted in a PFS of 4.1 months compared to 0.7 months with placebo in patients with small-cell lung cancer.