Update for September 21, 2021

Our mission at Prescribe Right is to offer budget-friendly products that provide the information you need to proactively plan for budget-busting drugs. To commemorate our 100th COVID-19 update we are offering access to the knowledgebase for 100 hours or 100 days whichever comes first, for only $100. This offer expires at 11:59 pm on Friday, September 24, 2021.

Regulatory Update

The FDA approved mobocertinib (Exkivity, Takeda), on 9/14/2021, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Patients should be identified through an approved lab test. Mobocertinib Prescribing Information was approved with a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

• ​The FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test, a sequencing companion diagnostic for mobocertinib, to identify NSCLC patients with EGFR Exon20 insertions.

The EMA recommended rejecting tanezumab for the treatment of pain associated with osteoarthritis.

Announced Research Updates

Zymeworks announced that in a 36 patient, Phase II trial, adding zanidatamab to capecitabine/oxaliplatin, 5FU/cisplatin 5FU/leucovorin/oxaliplatin resulted in an objective response rate of 75% in patients with metastatic HER2-positive gastroesophageal adenocarcinoma.

Ampio announced that in the 12-week, 1,034 patient, Phase III, AP-013 trial, treatment with LMWF5A decreased the WOMAC pain and function scores compared to placebo in patients with severe osteoarthritis of the knee.

Biogen announced that in the 12-week, 265 patient, Phase II, CONVEY trial, vixotrigine did not decrease the average daily pain score compared to placebo in patients with idiopathic or diabetes mellitus-associated small fiber neuropathy.

EQRx announced interim data from the Phase III GEMSTONE-301 trial, where patients treated with sugemalimab achieved progression-free survival of 9 months compared to 5.8 months with placebo in Chinese patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy.

Agenus announced that in a 155 patient, Phase II trial, treatment with balstilimab and zalifrelimab resulted in a 26% objective response rate (ORR) in patients with recurrent/metastatic cervical cancer.

Coherus BioSciences and Junshi Biosciences announced interim results from the 514 patient, Phase III JUPITER-06 trial, where adding toripalimab to paclitaxel/cisplatin resulted in PFS of 5.7 months and overall survival of 17 months compared to 5.5 months and 11 months with paclitaxel/cisplatin alone in patients with advanced esophageal squamous cell carcinoma.

Published Research Updates

In the 596 patient, Phase II, ESCORT-1st trial, treatment with camrelizumab added to paclitaxel and cisplatin resulted in overall survival of 15.3 months and progression-free survival of 6.9 months compared to 12 months and 5.6 months with paclitaxel and cisplatin alone in Chinese patients with untreated advanced or metastatic esophageal squamous cell carcinoma.

In a 60-week, 40 patient Phase I trial, GLS-5700 produced antibodies in all patients and 62% developed neutralizing antibodies. 70% of patients achieved 90% inhibition of Zika. Mice were injected with serum from the trial participants and 92% survived a potentially lethal injection of Zika

In a draft analysis, ICER found tezepelumab to reduce the annualized asthma exacerbation rate compared to non-biologic standard of care in patients with severe, uncontrolled asthma. In patients with eosinophilic and non-eosinophilic asthma, the benefit was smaller than what is considered clinically important. ICER found tezepelumab to be comparable to dupilumab in patients with eosinophilic asthma, but insufficient evidence to compare tezepelumab to omalizumab in patients with allergic asthma. Using a placeholder annual cost of $28,000 ICER estimated the cost per QALY was $430,000 with tezepelumab.