PharmaShots’ Key Highlights of Third Quarter 2020
PharmaShots’ Key Highlights of Third Quarter 2020
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B. Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.
Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK
Date – Sept 25, 2020
Product – NVX-CoV2373
- Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
- Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
- The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually
J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine
Date- Sept 24, 2020
Product- JNJ-78436735
- The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
- The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
- The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective
Illumina Acquired GRAIL for ~$8B
Date – Sept 22, 2020
Deal Value – ~$8B
- Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
- GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
- The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications
Fitbit to Launch ECG App in the US and EU in October 2020
Date – Sept 15, 2020
Product – ECG App
- Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
- The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
- Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel
Date – Sept 15, 2020
Product – Beovu (brolucizumab)
- The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
- The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
- Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of AEs
Gilead Acquired Immunomedics for ~$21B
Date – Sept 14, 2020
Deal Value – ~$21B
- Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
- The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
- Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21
Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics
Date – Sept 14, 2020
Deal Value – ~$4.5B
- Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
- The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
- Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory
Date – Sept 11, 2020
Product – Kisqali (ribociclib)
- Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
- Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
- New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively
AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B
Date – Sept 09, 2020
Deal Value – ~$2B
- I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
- AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
- The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity
Date – Sept 07, 2020
Product – Gavreto (pralsetinib)
- The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
- Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
- Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021
Date- Sept 01, 2020
Product- AZD1222
- AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
- The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
- The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia
GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19
Date- Sept 01, 2020
Product- VIR-7831
- The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
- The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
- Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21
World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan
Date – Aug 31, 2020
Product – CureApp
- On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
- CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
- The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app
GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma
Date – Aug 27, 2020
Product – Blenrep (belantamab mafodotin-blmf)
- The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
- The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
- Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017
Date – Aug 21, 2020
Product – Kesimpta (ofatumumab)
- The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
- ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
- In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21
Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B
Date – Aug 19, 2020
Deal Value – ~$6.5B
- J&J acquires Momenta in all cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
- The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
- Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases
Sanofi Acquired Principia Biopharma for ~$3.68B
Date – Aug 17, 2020
Deal Value – ~$3.6B
- Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
- The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
- The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases
Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India
Date – Aug 13, 2020
Product – Remdesivir
- The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
- In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
- The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients
Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B
Date – Aug 07, 2020
Deal Value – ~$2.125B
- Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
- The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
- Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs
Siemens Healthineers Acquired Varian for $16.4B
Date – Aug 04, 2020
Deal Value – ~$16.4B
- Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
- The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
- Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide
Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine
Date – Aug 03, 2020
Value – $2.1B
- The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
- The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
- Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally
Date – Jul 29, 2020
Product – Actemra/RoActemra (tocilizumab)
- The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
- The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
- Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral
Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease
Date- Jul 29, 2020
Deal Value- ~$2B+
- UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
- UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
- UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21
Date – Jul 27, 2020
Deal Value – ~$6B
- Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
- The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
- Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC
Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B
Date – Jul 10, 2020
Deal Value – ~$2.1B
- Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
- Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
- Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs
Bausch Health Spun off its Eye Health Business
Date – July 08, 2020
Product – N/A
- Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
- The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
- Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019
Date – Jul 07, 2020
Deal Value – ~$1B
- Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
- Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
- Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020
Date – Jul 01, 2020
Product – Bavencio (avelumab)
- The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
- Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
- Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval
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