On July 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its second quarter 2019 financial results on Thursday, August 1, 2019 (Press release, Iovance Biotherapeutics, JUL 26, 2019, View Source [SID1234537788]). Management will host a conference call to discuss these results and provide a corporate update at 4:30 p.m. EDT.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7574927. A live and archived webcast of the call can be accessed in the Investors section of the Company’s website at www.iovance.com or at the link: View Source

On July 26, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Hoffmann-La Roche, JUL 26, 2019, View Source [SID1234537786]). This decision is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 vs. 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95% CI: 0.62–0.96; p=0.017).

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This is the first Phase III study to show that a cancer immunotherapy-based combination significantly improved OS and PFS in the first-line treatment of ES-SCLC. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

"We are pleased to receive a positive opinion from the CHMP for our Tecentriq-based lung cancer combination for people living with extensive-stage small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The combination of Tecentriq and chemotherapy has the potential to address the high unmet need in this aggressive form of lung cancer where advances in survival have been very difficult to achieve."

Lung cancer is the leading cause of cancer death worldwide2 and SCLC accounts for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the "extensive stage", often meaning a poor prognosis.3 SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth and early development of metastatic disease.3

If the European Commission (EC) follows the EMA CHMP’s recommendation, this Tecentriq-based combination could represent a potential new treatment option for people across Europe with ES-SCLC. Based on the CHMP positive opinion, a final decision regarding the approval of this Tecentriq-based combination is expected from the EC in the near future.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) vs. chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC.

The study enrolled 403 people who were randomised equally (1:1) to receive:

Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm)
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS as determined by the investigator using RECIST v1.1 and OS in the ITT population.

A summary of the ITT data from the IMpower133 study that support this recommendation is included below:1

Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 vs. 10.3 months; HR=0.70, 95% CI: 0.54-0.91; p=0.0069) in the ITT population.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 vs. 4.3 months; HR=0.77; 95% CI: 0.62-0.96; p=0.017).
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
Serious adverse reactions occurred in 56.6% of people receiving Tecentriq plus chemotherapy compared to 56.1% of people receiving chemotherapy alone. The most common adverse reactions (≥20%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).
About SCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.3

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive triple-negative breast cancer.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On July 26, 2019 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2019 (Press release, AbbVie, JUL 26, 2019, View Source [SID1234537785]).

"We continue to see strong momentum in our business, as we delivered revenue and adjusted EPS ahead of our expectations for the quarter and announced plans to acquire Allergan, a transformative transaction that will provide scale and diversity to our business and position AbbVie for top-tier performance over the long term," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based on our strong performance year-to-date and our confidence in the outlook for the second half, we are raising our revenue and adjusted EPS guidance for 2019."

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Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net
revenues at the prior year’s foreign exchange rates.

Second-Quarter Results

Worldwide net revenues were $8.255 billion, a decrease of 0.3 percent on a GAAP basis. Adjusted net revenues were flat on a reported basis and increased 1.5 percent operationally.

Global HUMIRA net revenues of $4.870 billion decreased 6.1 percent on a reported basis, or 4.8 percent operationally. U.S. HUMIRA net revenues were $3.793 billion, an increase of 7.7 percent. Internationally, HUMIRA net revenues were $1.077 billion, a decrease of 35.2 percent on a reported basis, or 31.0 percent operationally, due to biosimilar competition.

Global net revenues from the hematologic oncology portfolio were $1.268 billion, an increase of 38.7 percent on a reported basis, or 39.1 percent operationally. Global IMBRUVICA net revenues were $1.099 billion, an increase of 29.3 percent, with U.S. net revenues of $886 million and international profit sharing of $213 million. Global VENCLEXTA net revenues were $169 million.

Global HCV net revenues were $784 million, a decrease of 19.4 percent on a reported basis, or 17.1 percent operationally. In the U.S., HCV net revenues of $396 million decreased 6.2 percent in the quarter. Internationally, HCV net revenues of $388 million decreased 29.5 percent on a reported basis, or 25.4 percent operationally.

On a GAAP basis, the gross margin ratio in the second quarter was 78.0 percent. The adjusted gross margin ratio was 82.7 percent.

On a GAAP basis, selling, general and administrative expense was 20.0 percent of net revenues. The adjusted SG&A expense was 19.6 percent of net revenues.

On a GAAP basis, research and development expense was 15.6 percent of net revenues. The adjusted R&D expense was 14.9 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

On a GAAP basis, the operating margin in the second quarter was 41.2 percent. The adjusted operating margin was 48.2 percent.

On a GAAP basis, net interest expense was $309 million. On a GAAP basis, the tax rate in the quarter was 8.1 percent. The adjusted tax rate was 8.7 percent.

Diluted EPS in the second quarter was $0.49 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.26.

Recorded a $2.3 billion increase in fair value of contingent consideration related to SKYRIZI future milestones and royalty payments, which was primarily due to a higher risk-adjusted cash flow forecast following regulatory approvals in the second quarter, as well as lower discount rates.

Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net
revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie and Allergan plc announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion. The proposed acquisition is transformational for both companies and provides immediate scale, diversity and profitability to AbbVie’s growth platform; enhances long-term R&D investment and sustained focus on innovative science; and increases global commercial scale to further maximize the value of Allergan’s portfolio. The combined company will produce robust cash flow to support continued dividend growth and reduction of debt levels. Additional information on the transaction can be found at www.abbvie.com/abbvie-allergan.html

AbbVie announced the U.S. Food and Drug Administration (FDA) and European Commission (EC) approvals of SKYRIZI (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. The approvals are based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis. SKYRIZI is part of a collaboration between Boehringer Ingelheim (BI) and AbbVie, with AbbVie leading development and commercialization globally.

At the World Congress of Dermatology, AbbVie presented new two-year data showing SKYRIZI patients with moderate to severe psoriasis maintained complete skin clearance. Longer-term results from the Phase 3 IMMhance study showed 73 percent and 72 percent of patients treated with continuous SKYRIZI experienced complete skin clearance (defined as static Physician Global Assessment (sPGA) 0 and Psoriasis Area and Severity Index 100, respectively) at week 94, among patients who achieved a sPGA 0/1 at week 28. No new safety findings were observed at two years.

At the European Congress of Rheumatology, AbbVie presented new long-term data from upadacitinib Phase 3 studies SELECT-EARLY and SELECT-COMPARE showing a significantly higher proportion of patients with rheumatoid arthritis treated with upadacitinib monotherapy or in combination with methotrexate (MTX) maintained clinical remission compared with MTX or adalimumab plus MTX, respectively, at 48 weeks. Additionally, findings from an integrated safety analysis across five studies in the SELECT Phase 3 clinical program support the well-characterized safety profile of upadacitinib in patients with moderately to severely active rheumatoid arthritis.

AbbVie announced FDA approval for VENCLEXTA (venetoclax) in combination with obinutuzumab as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients. The FDA reviewed the submission under the Real-Time Oncology Review pilot program and approval was based on data from the Phase 3 CLL14 trial evaluating VENCLEXTA in combination with obinutuzumab compared to patients who received chlorambucil plus obinutuzumab. This is the fourth approval and the fifth Breakthrough Therapy designation for VENCLEXTA. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, AbbVie presented over forty abstracts including results from the Phase 3 CLL14 trial of VENCLEXTA plus obinutuzumab in previously untreated CLL patients, results from the Phase 3 BELLINI trial of VENCLEXTA plus bortezomib and dexamethasone in patients with relapsed/refractory (r/r) multiple myeloma (MM) and results from the Phase 3 CLL12 trial of IMBRUVICA (ibrutinib) in the asymptomatic watch and wait population of CLL. AbbVie also presented new IMBRUVICA six-year and five-year data from the Phase 3 RESONATE and RESONATE-2 trials, respectively, evaluating its long-term safety and efficacy benefit in CLL/SLL patients. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.

Recent Events (continued)

AbbVie announced the FDA lifted the partial clinical hold placed on CANOVA, a Phase 3 trial evaluating VENCLEXTA for the investigational treatment of r/r MM. The CANOVA trial evaluates VENCLEXTA in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with r/r MM positive for the translocation (11;14) abnormality. The partial clinical hold removal is based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with MM.

AbbVie provided an update on the depatuxizumab mafodotin (Depatux-M) glioblastoma program, announcing that the Phase 3 INTELLANCE-1 study did not meet its primary endpoint of overall survival at the interim analysis and demonstrated no survival benefit for newly diagnosed patients receiving Depatux-M. The Independent Data Monitoring Committee responsible for interim analysis data review recommended stopping the study due to lack of survival benefit for patients receiving Depatux-M and enrollment in all ongoing Depatux-M studies has been halted. Results will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal.

At the American Academy of Neurology Annual Meeting, AbbVie presented six abstracts, including two oral presentations showing AbbVie’s research progress in difficult to treat neurological conditions. Investigators presented pharmacokinetics and safety/tolerability data on ABBV-951, a levodopa/carbidopa prodrug, delivering a 24-hour continuous, subcutaneous infusion under investigation for the treatment for advanced Parkinson’s disease. Investigators also presented data from a Phase 1, multiple-dose study of elezanumab in patients with relapsing forms of multiple sclerosis.

AbbVie announced that it has resolved U.S. HUMIRA (adalimumab) litigation with BI. Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States. The U.S. license for BI will begin on July 1, 2023. BI will pay royalties to AbbVie for licensing its HUMIRA patents and acknowledges the validity and enforceability of the licensed patents. AbbVie will make no payments of any form to BI.

AbbVie announced the acquisition of Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer. STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients. The collaboration broadens AbbVie’s oncology research platform to expand the development of potentially life-changing treatments for patients.

Full-Year 2019 Outlook

AbbVie is updating its GAAP diluted EPS guidance for the full-year 2019 from $7.26 to $7.36 to $5.69 to $5.79, representing growth of 56.8 percent at the midpoint, inclusive of a non-cash charge for SKYRIZI contingent consideration following regulatory approvals in the second quarter. AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2019 from $8.73 to $8.83 to $8.82 to $8.92, representing growth of 12.1 percent at the midpoint. The company’s 2019 adjusted diluted EPS guidance excludes $3.13 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

Statements Required by the Irish Takeover Rules

The earnings guidance contained in this press release constitutes a profit forecast for the purposes of the Irish Takeover Rules. In accordance with Rule 28.4 of the Irish Takeover Rules, this profit forecast shall be repeated in the proxy statement, including the scheme document and the reports required by Rule 28.3 of the Irish Takeover Rules shall be mailed to Allergan shareholders with the proxy statement, including the scheme document.

The directors of AbbVie accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors of AbbVie (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1% or more of any class of relevant securities of AbbVie Inc. may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013.

On July 26, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on a Type-II variation application for Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy (Press release, Bristol-Myers Squibb, JUL 26, 2019, View Source [SID1234537784]). The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

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"The positive opinion by the CHMP further validates the potential of this Empliciti-based combination to help patients with multiple myeloma who have relapsed or are refractory to prior therapies, a setting particularly in need of additional treatment options given the majority of patients with multiple myeloma will relapse," said Fouad Namouni, M.D., head, Oncology Development, Bristol-Myers Squibb.

The application is based on data from ELOQUENT-3, a randomized Phase 2 study evaluating pomalidomide and dexamethasone with or without Empliciti in patients with refractory or relapsed and refractory multiple myeloma. The U.S. Food and Drug Administration approved EPd for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI, in November 2018.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

About ELOQUENT-3

ELOQUENT-3 is a randomized Phase 2 study evaluating the addition of Empliciti to pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) in 117 patients with multiple myeloma who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a PI. Patients were randomized 1:1 to receive either EPd (n=60) or Pd alone (n=57) in 28-day cycles until disease progression or unacceptable toxicity. Patients in both the EPd and Pd arms received 4 mg of pomalidomide for days 1-21 of each cycle, and the weekly equivalent of 40 mg or 20 mg dexamethasone for patients ≤75 years or >75 years, respectively. In the EPd arm, Empliciti was administered at the dose of 10 mg/kg IV weekly for the first two cycles and 20 mg/kg monthly starting from cycle 3. The primary endpoint of the study was investigator-assessed progression-free survival.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Empliciti

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism of action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.

Empliciti was initially approved by the FDA in 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

U.S. FDA-APPROVED INDICATIONS FOR EMPLICITI

EMPLICITI (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.

EMPLICITI (elotuzumab) is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

IMPORTANT SAFETY INFORMATION

Infusion Reactions

Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide + dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)] and 3.3% in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)].

In the ELOQUENT-2 trial, all infusion reactions were Grade 3 or lower, with Grade 3 infusion reactions occurring in 1% of patients. The most common symptoms included fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose.

In the ELOQUENT-3 trial, the only infusion reaction symptom was chest discomfort (2%), which was Grade 1. All the patients who experienced an infusion reaction had them during the first treatment cycle.

If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.

Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.

Infections

In the ELOQUENT-2 trial (N=635), infections were reported in 81% of patients in the ERd arm and 74% in the Rd arm. Grade 3-4 infections were 28% (ERd) and 24% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in 22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5% (Rd). Herpes zoster was 14% (ERd) and 7% (Rd).

In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3-4 infections were reported in 13% (EPd) and 22% (Pd). Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported in 5% (EPd) and 1.8% (Pd).

Monitor patients for development of infections and treat promptly.

Second Primary Malignancies

In the ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd).

In the ELOQUENT-3 trial (N=115), invasive SPMs were 0% (EPd) and 1.8% (Pd).

Monitor patients for the development of SPMs.

Hepatotoxicity

In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (ERd) vs 0.6% (Rd). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Monitor liver enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.

Interference with Determination of Complete Response

EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.

Pregnancy/Females and Males of Reproductive Potential

There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

There is a risk of fetal harm, including severe life-threatening human birth defects, associated with lenalidomide and pomalidomide, and they are contraindicated for use in pregnancy. Refer to the respective product full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.

Adverse Reactions

ELOQUENT-2 trial:

Serious adverse reactions were 65% (ERd) and 57% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
The most common adverse reactions in ERd and Rd, respectively (≥20%) were fatigue (62%, 52%), diarrhea (47%, 36%), pyrexia (37%, 25%), constipation (36%, 27%), cough (34%, 19%), peripheral neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper respiratory tract infection (23%, 17%), decreased appetite (21%, 13%), and pneumonia (20%, 14%).
ELOQUENT-3 trial:

Serious adverse reactions were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).
The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).

On July 25, 2019 Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to improve protein therapies for unmet patient needs, reported that it will report its financial results for the second quarter and six months ended June 30, 2019, after the market close on Thursday, August 8, 2019, and will host a conference call and webcast at 4:30 PM Eastern Time (Press release, Pfenex, JUL 25, 2019, View Source [SID1234538433]).

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Conference Call & Webcast
Thursday, August 8th @ 4:30pm Eastern Time/1:30pm Pacific Time
Domestic:866-376-8058
International:412-542-4131
Webcast: View Source

Replays, Available Through August 15th:
Domestic:877-344-7529
International:412-317-0088
Replay Access Code:10133889

About Pfenex Inc.
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