On March 22, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has entered into a multi-RNA target alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal to discover and develop RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches (Press release, Evotec, MAR 22, 2021, View Source;announcements/press-releases/p/evotec-and-takeda-enter-strategic-rna-targeting-drug-discovery-and-development-alliance-6038 [SID1234576944]).

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Evotec and Takeda will jointly identify and develop small molecules targeting a range of RNA targets aligned with Takeda’s research and development areas. The collaboration will leverage Evotec’s extensive RNA targeting platform to optimally identify promising RNA sequences to target with small molecule ligands that can be developed into potentially first-in-class therapeutics.

Under the terms of the agreement, Evotec will receive significant research funding and will be eligible to receive discovery, pre-clinical, clinical, commercial and sales milestone payments of up to US$ 160 m per programme. Additionally, Evotec is entitled to tiered royalties on net sales of any products resulting from the collaboration.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Many highly validated targets have proven to be intractable via conventional protein targeting approaches. For this reason, Evotec has been pioneering RNA targeting strategies and approaches for quite some time. We are very excited about the opportunity to collaborate with Takeda in this field as both companies share the vision to jointly develop small molecule therapeutics against high value RNA targets that will deliver long awaited therapeutics."

"Takeda recognizes targeting RNA with small molecules as a promising new modality that has tremendous potential for much needed medicines for patients through modulating historically undruggable targets", said Dr Larry Hamann, Head, Drug Discovery Sciences, Takeda. "We are excited to be working with Evotec and their impressive capabilities."

On March 22, 2021 Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the closing of an oversubscribed $80 million financing (Press release, Aura Biosciences, MAR 22, 2021, View Source [SID1234576943]). The financing was led by Matrix Capital Management and Surveyor Capital (a Citadel company) with participation from new investors, including Rock Springs Capital, Adage Capital Management LP and Velosity Capital. Existing investors Medicxi, Advent Life Sciences, Lundbeckfonden Ventures, Arix Bioscience, Chiesi Ventures, Ysios Capital and Columbus Venture Partners also participated in the round.

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Aura intends to use the proceeds from this financing to advance the clinical development of its VDC technology platform, including the pivotal Phase 3 program for AU-011, the Company’s lead candidate in development for the first line treatment of choroidal melanoma, and ongoing research for additional programs in ocular oncology, as well as expanding the VDC technology into bladder cancer, the first non-ophthalmic solid tumor indication.

"Aura is pioneering the development of a new class of targeted therapies for life-threatening cancers with our novel VDC technology platform. This funding from a syndicate of distinguished investors enables us to advance AU-011 into a pivotal Phase 3 program for the first line treatment of choroidal melanoma, a rare, life- and vision-threatening form of cancer with no drugs approved. It also allows us to continue to expand the reach of our VDC technology in additional ocular oncology indications and in the treatment of solid tumors like bladder cancer where there is a high unmet medical need for better targeted therapies to treat early and reduce the incidence of metastasis," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

In connection with this financing, Karan Takhar, Senior Managing Director of Matrix Capital Management, will join Aura’s Board of Directors.

Mr. Takhar said, "Matrix believes in the long-term potential of Aura’s VDC technology to further strengthen the Company’s position as a leader in ocular oncology and beyond within other types of cancers in need of better treatment options. We look forward to supporting Aura’s leadership team through this next stage of pipeline growth and transition into late-stage development with the commencement of the AU-011 pivotal program."

About AU-011 (belzupacap sarotalocan)

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma cells (and other tumors) and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant melanoma cells with a pro-immunogenic cell death that is believed to activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastatic rate for patients with this life-threatening disease. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

On March 22, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported on 19 March 2021 that the independent Data Safety and Monitoring Board (iDSMB) has recommended continuation of the global Phase III AGENT study with 440 patients, in accordance with the study design for the drug candidate, arfolitixorin (Press release, Isofol Medical, MAR 22, 2021, View Source [SID1234576938]). In connection with this, Isofol invites investors, analysts and media to a conference call and webcast on March 22, 2021 at 14:00 (CET).

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The presentation will be held by Isofol’s CEO Ulf Jungnelius in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

Date and time
March 22, 2021 at 14:00 (CET)

Webcast link
View Source

Phone number
Call in details will be made available at the following link in good time before the start of the presentation:
View Source

After the presentation, a recording of the webcast will be available on the webcast link.

The information was submitted for publication, through the agency of the contact person set out above, at 08:50 CET on March 22, 2021.

About the AGENT study
The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On March 22, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported its financial results for full year ended December 31, 2020, along with corporate progress (Press release, Everest Medicines, MAR 22, 2021, View Source [SID1234576931]).

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"Despite the macro challenges and volatility experienced around the world throughout 2020, Everest Medicines continues to position itself for tremendous long-term growth, including the significant momentum we have gained across our promising pipeline of innovative drug candidates," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We have continued to progress a number of our lead therapeutic candidates, initiating late-stage clinical trials for sacituzumab govitecan-hziy in two difference breast cancer indications with high unmet medical need, completing a Phase 3 bridging trial, and this month, had our New Drug Application (NDA) of eravacycline accepted by the China National Medical Products Administration (NMPA) for the treatment of complicated intra-abdominal infections (cIAI). We have also obtained Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN) in China."

"Looking forward, we expect 2021 to be another fruitful year for Everest Medicines," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We will continue to focus on executional excellence across our clinical development programs as we also prepare the Company to become a commercial organization and build on our plans to expand our international business, manufacturing and discovery efforts. We are confident Everest Medicines is well positioned to deliver value for our patients and stakeholders."

Business Review

The Company was successfully listed on The Stock Exchange of Hong Kong Limited (the "Stock Exchange") on 9 October 2020 (the "Listing Date"). Since then, the Company has made significant progress advancing its product pipeline and enhancing its business operations.

Sacituzumab govitecan-hziy (TrodelvyTM), our anchor drug candidate in oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).

Development achievements during the Reporting Period:
– On 2 November 2020, the China NMPA approved a Clinical Trial Application (CTA) for sacituzumab govitecan- hziy for a regional Phase 3 registration clinical trial, EVER-132-002, designed to assess and compare the efficacy and safety of sacituzumab govitecan-hziy versus Treatment of Physician’s Choice (TPC) in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer (HR+/HER2- mBC) who received at least two, and no more than four, systemic chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Mainland China, Taiwan and South Korea. On 9 December 2020, the first patient was dosed in this Phase 3 study.

– On 3 November 2020, the first patient was dosed in China into our EVER-132-001 Phase 2b registration clinical trial evaluating sacituzumab govitecan-hziy for the treatment of patients with metastatic triple negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. EVER-132-001 will enroll approximately 80 mTNBC patients in China. It is worth mentioning that sacituzumab govitecan-hziy has also been included in the newly updated 2020 Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

Post-Reporting Period (expected) milestones and achievements:
– On 6 January 2021, we submitted a NDA to the Health Sciences Authority (HSA) of Singapore for sacituzumab govitecan-hziy for the treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease.

– On 6 January 2021, the China Center for Drug Evaluation (CDE) of the China NMPA approved a CTA for sacituzumab govitecan-hziy for the treatment of patients with mUC. With this CTA, we plan to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) therapy. Subjects will be randomized to receive either sacituzumab govitecan-hziy or TPC, including paclitaxel, docetaxel, and vinflunine.

– In the second half of 2021, we expect to read-out topline results of the China EVER-132- 001 Phase 2b registration clinical trial for mTNBC and initiate patient enrollment in China as part of the global Phase 3 TROPiCS-04 clinical trial for metastatic urothelial cancer (mUC).

– Our partner Gilead Sciences, Inc. (Gilead) anticipates obtaining full U.S. Food and Drug Administration (US FDA) approval for mTNBC and accelerated US FDA approval for mUC in the first half of 2021, as well as releasing topline results from the global Phase 3 TROPiCS-02 study HR+/HER2- mBC in the second half of 2021. Phase 1 TROPiCS-03 basket study continues to progress, Gilead expects to provide an update, particularly in non-small cell lung cancer, in the second half of 2021.

Nefecon, our anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide in the development for the treatment of IgAN.

Development achievements during the Reporting Period:
– On 10 November 2020, our licensing partner, Calliditas, reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon versus placebo in 199 patients with primary IgAN. The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. The efficacy data indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease for IgAN patients. In addition, results showed that Nefecon was generally well-tolerated.

– On 2 December 2020, the China CDE of the NMPA recommended and subsequently granted BTD for Nefecon for the treatment of IgAN. We are currently enrolling patients as part of the Phase 3 global registrational study NefIgArd to support approval for IgAN patients in China.

Post-Reporting Period (expected) milestones and achievements:
– We expect to complete patient enrollment in China into the NeflgArd Phase 3 global registration study for IgAN in the first half of 2021.

Eravacycline (XeravaTM), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistance (MDR) infections, including MDR Gram-negative infections.

Development achievements during the Reporting Period:
– On 27 October 2020, we completed a Phase 3 bridging clinical trial of eravacycline which enrolled a total of 144 treated patient, for the treatment of cIAI in China.

Post-Reporting Period (expected) milestones and achievements:
– China NMPA accepted a NDA for eravacycline for the treatment in cIAI in China in March 2021 as our first NDA submission in China.

Other assets

Post-Reporting Period (expected) milestones and achievements:
– We expect to announce topline results in the Phase 3 global clinical trial for Taniborbactam for complicated urinary tract infections (cUTI) in 2021.
– We plan to initiate Phase 2 clinical trial for FGF401 for the treatment of hepatocellular carcinoma in China in the second half of 2021.

Corporate Development

– In January 2021, we entered into an amended license agreement with Spero Therapeutics under which the relevant patents for SPR206 will be assigned to us in Greater China, South Korea and certain Southeast Asian countries. SPR206 is in clinical development as an innovative option for the treatment of MDR Gram-negative bacterial infections.

– On 18 February 2021, we appointed Kevin Guo as our Chief Commercial Officer. Mr. Guo has more than 22 years of commercial leadership and business management experience across a number of multinational pharmaceutical companies.

– We have been selected as a constituent stock of the Hang Seng Composite Index, the Hang Seng Healthcare Index and the Hang Seng Hong Kong-Listed Biotech Index in accordance with the latest index series release by Hang Seng Indexed Company Limited, with effect from 15 March 2021. Being selected as a constituent stock of the above Hang Seng Indexes fulfills the eligibility criteria for Southbound Trading under the Stock Connect Scheme, which is a channel that facilitates stock trading and investment between Hong Kong and a broader base of China investors.

Future Development

We will continue to build a leading biopharmaceutical company focused on the development and commercialization of globally innovative therapies, initially in Greater China and other Asia Pacific markets. To achieve the goal, we will strive to advance our existing drug candidates into and through registrational trials and will seek the most efficient approval pathways. In the meantime, we will continue to expand our innovative drug portfolio in areas of high unmet medical needs across our chosen therapeutic areas through in-licensing and building organic discovery capabilities. To support our anticipated commercial launch of multiple late-stage products, we have commenced building a commercial team with deep knowledge of sales, marketing and market access strategies across a range of therapeutical areas. In addition, we are building our own GMP/GSP manufacturing facilities in China in order to ensure stable and sufficient long term drug supply and to optimize the cost of goods.

Financial Highlights

IFRS Numbers:

Research and development expenses increased by RMB226.5 million to RMB377.4 million for the year ended 31 December 2020, from RMB150.9 million for the year ended 31 December 2019, primarily due to additional clinical trials of our drug candidates and the expansion of our research and development headcount.

General and administrative expenses increased by RMB223.9 million to RMB277.8 million for the year ended 31 December 2020, from RMB53.9 million for the year ended 31 December 2019, primarily due to initial public offering ("IPO") costs and the increase in employee remuneration in connection with organization expansion.

The loss from fair value change in financial instruments issued to investors increased by RMB4,901.5 million to RMB4,938.0 million for the year ended 31 December 2020, from RMB36.5 million for the year ended 31 December 2019, primarily attribute to significant increase in the per share fair value upon the completion of the IPO of the Company when re-measuring convertible redeemable preferred shares previously issued to the investors before conversion into the Company’s ordinary shares.

Net loss for the year ended 31 December 2020 increased to RMB5,658.2 million, from RMB214.5 million for the year ended 31 December 2019, primarily due to the loss of RMB4,938.0 million in fair value change in financial instruments issued to investors, which was a non-cash and one-time adjustment upon the listing as required under the International Financial Reporting Standard ("IFRS").
Non-IFRS Measure:

Adjusted loss for the year[1] was RMB602.9 million for the year ended 31 December 2020, representing an increase of RMB439.8 million from RMB163.1 million for the year ended 31 December 2019, primarily due to the increase in research and development expenses and general and administrative expenses.

On March 22, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IMpower010 study evaluating Tecentriq (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis (Press release, Genentech, MAR 22, 2021, View Source [SID1234576928]). Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomized Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.

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Follow-up will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. Safety for Tecentriq was consistent with its known safety profile and no new safety signals were identified. Results from the IMpower010 study will be presented at an upcoming medical meeting and submitted to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency.

"With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible."

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in the U.S. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy), and also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.

About the IMpower010 study

IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

About lung cancer

According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021, and NSCLC accounts for 80-85% of all lung cancers. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as their first treatment when their lung cancer:
has spread or grown, and
their cancer tests positive for "high PD-L1", and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may also be used when their lung cancer:
has spread or grown, and
they have tried chemotherapy that contains platinum, and it did not work or is no longer working
if their tumor has an abnormal "EGFR" or "ALK" gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of the skin or the whites of the eyes
severe nausea or vomiting
pain on the right side of their stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
their voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in their amount of urine
blood in their urine
swelling of their ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to their chest area
have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
nausea
cough
shortness of breath
decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or View Source

Report side effects to Genentech at 1-888-835-2555.

Please see View Source for full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.